KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF- pyrithione zinc shampoo

KeraCare Dry and Itchy Scalp Anti-Dandruff by

Drug Labeling and Warnings

KeraCare Dry and Itchy Scalp Anti-Dandruff by is a Otc medication manufactured, distributed, or labeled by Avlon Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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ASK DOCTOR

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

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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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STOP USE

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

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. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.

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).

PRINCIPAL DISPLAY PANEL

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

Product NDC

63766-002

INGREDIENTS AND APPEARANCE

KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63766-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63766-002-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2009
2	NDC: 63766-002-02	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2009
3	NDC: 63766-002-03	15 mL in 1 POUCH; Type 0: Not a Combination Product	06/18/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/18/2009

Labeler - Avlon Industries, Inc. (121278626)

Establishment
Name	Address	ID/FEI	Business Operations
Avlon Industries, Inc.		121278626	manufacture(63766-002)