Keracare Dry And Itchy Scalp Anti-dandruff Lotion
FDA Label NDC 63766-003

11 label sections · Submitted to the FDA by Avlon Industries, Inc. · 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 active ingredient, 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

Active Ingredient

Pyrithione Zinc 1%

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

-----------------------------------------------------------------------------------------------------

Otc - Ask Doctor

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

-----------------------------------------------------------------------------------------------------

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.

-----------------------------------------------------------------------------------------------------

Otc - Stop Use

Stop use and ask a doctor if

■ Condition worsens or does not improve with regular use.

-----------------------------------------------------------------------------------------------------

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

For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing
Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner
throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style
as usual.

Inactive Ingredients

Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Betaine, Aloe Barbadensis Leaf Juice, Cetearyl
Alcohol, Cetyl Alcohol, Glycerin, Stearamidopropyl Dimethylamine, Behentrimonium Chloride,
Linum Usitatissimum (Linseed) Seed Extract, Quaternium-80, Piroctone Olamine, Menthol,
Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6,
Fragrance/Parfum, Polyquaternium-10, Dipropylene Glycol, Propanediol, Caprylyl Glycol,
Phenoxyethanol, Citric Acid, Polyacrylamide, Benzyl Salicylate, Hexyl Cinnamal, Linalool.

* Please review the disclaimer below.