Drug Facts
Active Ingredient
Pyrithione Zinc 1%
Keracare Dry And Itchy Scalp Anti-dandruff Shampoo
FDA Label NDC 63766-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avlon Industries, Inc. for the product Keracare Dry And Itchy Scalp Anti-dandruff (NDC 63766-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-Dandruff, Anti-Seborrheic Dermatitis
Indications & Usage
Use for the relief of scalp flaking, itching and irritation associated with
dandruff and seborrheic dermatitis.
Warnings
■ For external use only
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Otc - Ask Doctor
Ask a doctor before use if you have
■ seborrheic dermatitis that covers large areas of your body.
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Otc - When Using
When using this product
■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.
■ Use caution in exposing skin to sunlight after applying this product. It may
increase your tendency to sunburn for up to 24 hours after application.
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Otc - Stop Use
Stop use and ask a doctor if
■ Condition worsens or does not improve with regular use.
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Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.
Directions
• Apply to wet hair and gently lather with fingertips. Rinse and repeat if necessary. Shampoo with keraCare ® Hydrating Detangling Shampoo for a final sudsing. For best result follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner. • For use in conjunction with Affirm ®Conditioning Relaxer System ; use for the first sudsing in the final step {Normalizing}, Rinse and apply Affirm ®Normalizing shampoo for second sudsing.
Inactive Ingredients
Aqua/Water/Eau, Ammonium Laureth Sulphate, Ammonium Lauryl Sulfate, Cocamide DIPA, Distearyl Phthalic Acid Amide, Cocamidopropyl Betaine, Cetyl Alcohol, , Polyquaternium-28, Glycol Stearate, Menthol, Magnesium Aluminum Silicate, Propylene Glycol, Lamium Album Flower Extract, Pinus Sylvestris Leaf Extract, Arctium Majus Flower Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Arnica Montana Flower Extract, Nasturtium Officinale Flower/Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Calendula Officinalis Flower Extract, Tilia Cordata Flower Extract, Centaurea Cyanus Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Flower/Leaf/Stem Extract, fragrance/parfum, Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Blue 1 (Cl 42090)
Other
©2014 Manufactured by Avlon Industries, Inc.,
1999 N. 15th Avenue, Melrose Park, IL 60160 USA
77 Oxford Street, London, W1D 2ES, UK www. Avlon.com
Package Label. Principal Display Panel
KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Shampoo is a superb treatment specifically formulated to alleviate dry and itchy scalp conditions hair. It:•Deeply cleanses hair and scalp, eliminating flakiness •Contains moisturizers that help protect the hair and scalp against dryness, which is a major cause of itchiness • Detangles hair • Excellent for both natural and chemically treated hair.
* Please review the disclaimer below.
