KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF- pyrithione zinc shampoo 
Avlon Industries, Inc.

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KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

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

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Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

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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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Stop use and ask a doctor if

■ Condition worsens or does not improve with regular use.

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Keep out of reach of children.  If swallowed, get medical help or contact

a Poison Control Center right away.

Directions

Inactive Ingredients

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate,

Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl

Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus

(Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf

Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10,

Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate,

Hexyl Cinnamal, Linalool, Blue 1 (CI 42090).

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

Product NDC

63766-002

Label

KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
APPLE (UNII: B423VGH5S9)  
PROPANEDIOL (UNII: 5965N8W85T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
MENTHOL (UNII: L7T10EIP3A)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
LEMON PEEL (UNII: 72O054U628)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID (UNII: 71X53V3RZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63766-002-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2009
2NDC:63766-002-02950 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2009
3NDC:63766-002-0315 mL in 1 POUCH; Type 0: Not a Combination Product06/18/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03206/18/2009
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIBusiness Operations
Avlon Industries, Inc.121278626manufacture(63766-002)

Revised: 2/2024
Document Id: 1285f73f-13a0-d454-e063-6294a90a905c
Set id: 6e7524d7-b280-485a-815e-8af078e8acda
Version: 7
Effective Time: 20240229
 
Avlon Industries, Inc.