HEAD & SHOULDERS CLASSIC CLEAN SHAMPOO
Head & Shoulders Classic Clean is a pyrithione zinc 1% anti-dandruff shampoo formulated to control flaking, itching, and irritation associated with dandruff and seborrheic dermatitis . The Microbiome Balance formula targets the root cause of dandruff by maintaining a balanced scalp microbiome, releasing protective ingredients that penetrate deep into pores to prevent stubborn dandruff from returning with regular use . Clinically proven to provide up to 100% visible flake control and up to 72 hours of itch protection, the pH-balanced formula is dermatologically tested and suitable for daily use on all hair and scalp types . For external use only. Avoid contact with eyes. Discontinue if condition worsens. Keep out of reach of children .
HEAD & SHOULDERS CLASSIC CLEAN SHAMPOO
PRIMARY USES
1. Effective Management and Prevention of Dandruff (Seborrheic Dermatitis)
Primary Use: Clinically proven formula containing pyrithione zinc 1% that targets the root cause of dandruff by combating Malassezia fungus, controlling flaking, itching, and irritation associated with dandruff and seborrheic dermatitis with regular use .
How it helps: For the dermatologist and primary care physician, dandruff is a chronic scalp condition caused by Malassezia yeast overgrowth that triggers inflammation and accelerated skin cell turnover. The Classic Clean formulation deposits active ingredient on the scalp during washing, providing up to 100% visible flake control with regular use . The microbiome-balancing formula helps maintain a healthy pH and scalp microbiome balance, addressing the underlying cause rather than just treating symptoms . For the patient, this means reliable, long-term dandruff control that returns confidence in everyday situations without fear of visible flakes or scalp discomfort.
2. Microbiome-Balancing Formula for Scalp Health Maintenance
Primary Use: Features Microbiome Balance technology that targets the root cause of dandruff by maintaining a balanced scalp microbiome, releasing protective ingredients that penetrate deep into pores to prevent stubborn dandruff from returning with regular use .
How it helps: For the dermatologist, scalp microbiome imbalance is central to dandruff pathogenesis. The Classic Clean formulation releases 2x more protective ingredients (vs. deep cleanse line) that go into the pores to prevent stubborn dandruff from coming back . The pH-balanced formula with added antioxidants provides gentle care for both scalp and hair while maintaining the skin’s natural protective barrier . For the patient, this means progressive improvement with each wash—scalp hydration improves, irritation reduces, and dandruff recurrence is prevented, breaking the cycle of chronic flaking.
3. Dermatologically Tested Formula for All Hair and Scalp Types
Primary Use: Dermatologically tested, pH-balanced formula suitable for both men and women, safe for daily use on all hair and scalp types including normal, oily, and dry scalp conditions .
How it helps: For the general practitioner and patient, selecting an anti-dandruff shampoo that works for their specific hair type should not be complicated. Classic Clean is clinically proven to be effective for most dandruff cases while remaining gentle enough for everyday use . The formula is dermatologically tested, pH-balanced, and boosted with antioxidants for gentle care of scalp and hair . For the patient, this means a single, reliable product that can be used daily without worrying about irritation, regardless of hair type or texture.
4. Provides Extended Protection Between Washes
Primary Use: Provides up to 72 hours of dandruff dryness and itch protection with regular use, ensuring scalp remains flake-free and comfortable between shampoos .
How it helps: For the patient managing an active lifestyle, daily washing may not always be possible or convenient. The Classic Clean formula provides extended protection, with clinical testing showing up to 72 hours of dandruff control with regular use . The pyrithione zinc active ingredient remains active on the scalp even between washes, continuing to combat Malassezia yeast and prevent symptom recurrence. For the patient, this means flexibility in their hair washing routine without compromising dandruff control—ideal for travel, busy schedules, or those who prefer washing every other day.
SECONDARY USES
1. Management of seborrheic dermatitis of the scalp: For patients diagnosed with mild to moderate seborrheic dermatitis, the 1% pyrithione zinc formulation helps control the inflammatory scaling and itching characteristic of this chronic condition, with clinical efficacy demonstrated for reducing both visible flakes and associated erythema .
2. Scalp psoriasis adjunctive care (mild cases): For patients with mild scalp psoriasis, the moisturising and scale-softening properties combined with the antifungal action may provide symptomatic relief as part of a broader treatment plan, though medical guidance should be sought for moderate to severe cases.
3. Prevention of dandruff recurrence in maintenance phase: For patients who have successfully cleared active dandruff, using Classic Clean 2-3 times weekly helps maintain scalp health and prevent relapse, with the microbiome-balancing formula supporting ongoing scalp ecosystem stability .
4. Post-chemotherapy scalp care (off-label, physician-guided): For oncology patients experiencing scalp flaking and irritation following chemotherapy, the gentle, dermatologically tested formula may be used under oncologist guidance to manage treatment-related scalp symptoms, though medical clearance should be obtained.
5. Family dandruff management: For households where multiple family members experience dandruff, the Classic Clean formulation is suitable for men, women, and teenagers, providing consistent dandruff control across different hair types and severities with a single product .
1. BASIC IDENTIFICATION ATTRIBUTES
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Device Type: Over-the-counter (OTC) topical anti-dandruff shampoo; non-prescription medication
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Brand: Head & Shoulders
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Designation: Classic Clean, Classic Clean Anti-Dandruff Shampoo
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Active Ingredient: Pyrithione zinc 1% w/vÂ
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Therapeutic Classification: Anti-dandruff / Antifungal (OTC monograph part 358H)
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NDC Code: 37000-071 (source NDC)Â
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Labeler: The Procter & Gamble Manufacturing CompanyÂ
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Available Sizes: 50mL, 90mL, 95mL, 250mL, 400mL, 700mL, 950mL, 1000mL, 1180mL, 1280mLÂ
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Formulation Variants: Classic Clean Shampoo (standard), Classic Clean 2-in-1 (shampoo + conditioner)Â
2. TECHNICAL & PERFORMANCE PROPERTIES
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Active Ingredient Concentration: 1 gram pyrithione zinc per 100 mLÂ
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Mechanism of Action: Pyrithione zinc exhibits antifungal activity against Malassezia species (primarily M. globosa and M. restricta), inhibiting yeast growth and reducing inflammatory response, thereby controlling flaking, scaling, and pruritus associated with dandruff and seborrheic dermatitisÂ
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Clinical Efficacy: Up to 100% visible flake protection with regular use; clinically provenÂ
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Duration of Protection: Up to 72 hours dandruff dryness and itch protection with regular useÂ
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Microbiome Technology: Microbiome Balance formula targets root cause by maintaining healthy pH and scalp microbiome balance; releases 2x more protective ingredients (vs. deep cleanse line)Â
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Dermatological Testing: Dermatologically tested; pH-balancedÂ
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Fragrance: Classic Clean scentÂ
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Consistency: Liquid shampoo (light blue color due to added dyes)Â
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Inactive Ingredients (Classic Clean Shampoo): Water, sodium laureth sulfate, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, cocamidopropyl betaine, sodium xylenesulfonate, fragrance, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33Â
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Preservatives: Methylchloroisothiazolinone, methylisothiazolinoneÂ
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Shelf Life: Not specified; typical for OTC shampoo products when stored properly
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Allergen Information: Contains fragrance; may contain known allergens (hexyl cinnamal, linalool) as fragrance componentsÂ
3. PHYSICAL & OPERATIONAL PROPERTIES
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Physical Form: Viscous liquid; opaque; light blue colourÂ
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Route of Administration: Topical (scalp and hair)
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Preparation: Shake bottle before use. No additional preparation required.
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Application Instructions: Wet hair thoroughly. Massage shampoo onto scalp, working into a lather. Leave on scalp briefly (allows active ingredient to contact affected areas). Rinse thoroughly. Repeat if desired .
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Frequency of Use: For best results, use at least twice weekly. For maximum dandruff control, use every time you shampoo .
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Treatment Duration: Use regularly as directed; improvement typically visible within 2 weeks of consistent use. Continued use prevents recurrence .
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Storage Conditions: Store in a cool, dry place. Keep bottle tightly closed when not in use. Avoid extreme temperatures. Protect from direct sunlight.
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Portion Size: Approximately one to two tablespoon amount per wash (depends on hair length and thickness)
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Compliance: For maximum efficacy, use every time you shampoo rather than intermittently .
4. SAFETY & COMPLIANCE ATTRIBUTES
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OTC Monograph Status: Approved under FDA OTC Monograph Final Part 358H for anti-dandruff useÂ
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FDA Status: Most OTC drugs are not individually reviewed and approved by FDA; marketed under compliance with applicable regulations and policiesÂ
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Indications: Helps prevent recurrence of flaking and itching associated with dandruffÂ
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Off-Label Uses: May be used to control seborrheic dermatitis symptoms (itchiness, flaking, irritation) of the scalpÂ
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External Use Only: For topical use on scalp and hair only. Not for ingestion .
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Eye Contact Warning: Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water .
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When to Stop Use: Discontinue if condition worsens or does not improve after regular use of product as directed. Consult a doctor .
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Paediatric Safety: Keep this and all drugs out of reach of children .
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Ingestion Warning: If swallowed, get medical help or contact a Poison Control Center right away .
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Quality Assurance: Manufactured by The Procter & Gamble Manufacturing CompanyÂ
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Regulatory Information: NDC Code 37000-071 (source NDC)Â
1. SAFETY PRECAUTIONS
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For external use only: This product is formulated for topical application to scalp and hair. Do not ingest. If swallowed, contact a Poison Control Center immediately .
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Avoid eye contact: Pyrithione zinc can cause eye irritation. If shampoo enters eyes, rinse immediately and thoroughly with water. If irritation persists, seek medical advice .
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Discontinue if irritation develops: While generally well-tolerated, some individuals may experience scalp irritation, dryness, or allergic contact dermatitis. Discontinue use if condition worsens or does not improve after regular use as directed .
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Keep out of reach of children: Product contains active pharmaceutical ingredient. Store in a location where young children cannot access it to prevent accidental ingestion or misuse .
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Appropriate use duration: For dandruff management, regular use is required for maintenance. Do not expect immediate results after single use. Improvement typically occurs after 2 weeks of regular use .
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Do not use on broken or irritated scalp: Avoid applying to areas of the scalp that are actively bleeding, oozing, or showing signs of infection. Seek medical advice for severe scalp conditions .
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Patch test for sensitive individuals: For patients with known sensitive skin or history of contact dermatitis, consider patch testing on a small area of skin before full scalp application.
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Not a treatment for systemic fungal infections: This product is intended for topical management of dandruff and seborrheic dermatitis of the scalp only. It is not effective for systemic fungal infections or fungal infections on other body sites.
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Drug interactions: No known significant drug interactions. However, patients using topical prescription scalp medications (e.g., corticosteroids, other antifungals) should consult their physician before combining with this product.
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Pregnancy and lactation: Pyrithione zinc 1% shampoo is generally considered safe for use during pregnancy and breastfeeding when used as directed for dandruff management. However, patients should consult their healthcare provider if concerned .
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Proper disposal: Dispose of empty bottle in household waste. Do not recycle unless local facilities accept shampoo bottles. Do not pour unused product down drains.
2. FIRST AID MEASURES
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Eye contact: If shampoo enters eyes, rinse immediately with plenty of lukewarm water for at least 15 minutes. Hold eyelids open during rinsing. If irritation, redness, or pain persists after rinsing, seek medical attention .
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Ingestion: If swallowed, do not induce vomiting. Rinse mouth with water. Contact a Poison Control Center immediately or seek emergency medical attention. Provide product container or label to medical personnel .
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Skin irritation (mild): Discontinue product use. Rinse affected area thoroughly with lukewarm water. Apply a gentle, fragrance-free moisturiser if dryness develops. If irritation persists beyond 48 hours, consult a healthcare professional.
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Allergic contact dermatitis (rash, itching, redness): Discontinue use immediately. Wash scalp thoroughly with water. Apply cool compresses if itching is severe. Consult a dermatologist if symptoms are widespread or persistent.
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Accidental ingestion by child: Call Poison Control Center immediately (1-800-222-1222 in US) or seek emergency medical care. Do not induce vomiting unless directed by medical professional.
3. FIRE FIGHTING MEASURES
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Flammability: Shampoo is water-based and not considered flammable. However, plastic packaging may burn if exposed to open flame.
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Extinguishing Media: Use water spray, foam, dry chemical powder, or carbon dioxide (COâ‚‚). No special restrictions apply.
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Fire Response: For small fires involving packaging, use appropriate extinguisher. For large fires, evacuate area. Firefighters should wear self-contained breathing apparatus (SCBA) and full protective gear for fires involving burning plastics.
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Hazardous decomposition products: Burning plastic packaging may release irritating fumes including carbon monoxide and acrid smoke.
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