Drug Facts
Active Ingredient
Pyrithione Zinc 1%
Keracare Dry And Itchy Scalp Anti-dandruff Lotion
FDA Label NDC 63766-003
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 63766-003). 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
Distribute throughout hair after shampooing with KeraCare® Dry & Itchy Scalp
Anti-Dandruff Moisturizing Shampoo.
Inactive Ingredients
Aqua/Water/Eau, Cyclopentasiloxane, Dimethicone, Cetearyl Alcohol, Glycerin,
Stearalkonium Chloride, PEG-40 Castor Oil, Polyquaternium-32, Mineral Oil,
Dicetyldimonium Chloride, Sodium PCA, Panthenol, Polysorbate 20, Polyquaternium-10,
Menthol, Ethylhexyl Dimethyl PABA, Fragrance/Parfum, Tocopheryl Acetate,
Methylisothiazolinone, Citric Acid, Magnesium Citrate, Simethicone, Polyacrylamide,
Benzyl Salicylate, Hexyl Cinnamal, Linalool.
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
The technologically-advanced KeraCare® Dry & Itchy Scalp Anti-Dandruff
Moisturizing Conditioner effectively combats a dry and itchy scalp as it moisturizes
and conditions hair. It: • Actively relieves itching • Soothes scalp • Rehydrates and
rebuilds damaged fibers • Detangles hair • Regular use helps prevent dryness, itching
and flaking.
labeconditioner_sample
labeconditioner_8oz
labeconditionerr32oz
* Please review the disclaimer below.
