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KeraCare Dry and Itchy Scalp Anti-Dandruff

Dosage form: lotion/shampoo
Ingredients: Pyrithione Zinc 10mg in 1mL
Labeler: Avlon Industries, Inc.
NDC Code: 63766-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

Drug Facts

Active Ingredient                                                                              

Pyrithione Zinc 1%

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Use for the relief of scalp flaking, itching and irritation associated with

dandruff and seborrheic dermatitis.

Warnings

■ For external use only

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

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.

Stop use and ask a doctor if

■ Condition worsens or does not improve with regular use.

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.

©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.

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labeconditioner_8oz

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KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-003
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
DIMETHICONE 
CETOSTEARYL ALCOHOL 
GLYCERIN 
STEARALKONIUM CHLORIDE 
PEG-40 CASTOR OIL 
POLYQUATERNIUM-32 (30000 MPA.S AT 2%) 
MINERAL OIL 
DICETYLDIMONIUM CHLORIDE 
SODIUM PYRROLIDONE CARBOXYLATE 
PANTHENOL 
POLYSORBATE 20 
POLYQUATERNIUM-10 (125 MPA.S AT 2%) 
MENTHOL 
PADIMATE O 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLISOTHIAZOLINONE 
ANHYDROUS CITRIC ACID 
MAGNESIUM CITRATE 
POLYACRYLAMIDE (1500 MW) 
BENZYL SALICYLATE 
.ALPHA.-HEXYLCINNAMALDEHYDE 
LINALOOL, (+/-)- 
Packaging
#Item CodePackage Description
1NDC:63766-003-01240 mL in 1 TUBE
2NDC:63766-003-02950 mL in 1 BOTTLE
3NDC:63766-003-0315 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/18/2009
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIOperations
Avlon Industries, Inc.121278626manufacture(63766-003)

Revised: 06/2015
 
Avlon Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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