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

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]

Drug Facts

Active Ingredient                                                                              

Pyrithione Zinc 0.2%

Purpose

Anti-Dandruff

INDICATIONS & USAGE

Use for the relief of flaking, itching and irritation Associated with dandruff.

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

Warnings

■ For external use only

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

Ask a doctor if

■ Condition worsens or does not improve with regular use.

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

WHEN USING

When using this product

■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

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

STOP USE

Stop use and ask a doctor if

■ Condition worsens or does not improve with regular use.

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

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 daily or several times a day as needed.
• Massage gently into scalp.
• Do not rinse out.

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

Inactive Ingredients

Water/Aqua/Eau, Mineral Oil, Petrolatum, Beeswax, Cetyl Alcohol, Lanolin, Sodium Borate, Polysorbate 60,

Polysorbate 80, Carthamus Tinctorius (Safflower) Seed Oil, Eugenia Caryophyllus (Clove) Flower Extract,

Glyceryl Stearate, Menthol, Sulfur, Perfume, BHT, Methylisothiazolinone, A-Isomenthyl Ionone, Benzyl Alcohol,

Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Butylphenyl Methylpropional, Cinnamal Alcohol, Citronellol,

Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Hydroxyisohexyl 3-cyclohexane Carboxaldehyde, d-Limonene, Linalool.

SPL UNCLASSIFIED SECTION

©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

KeraCare® Anti-Dandruff Spot Itch Lotion controls itching and dandruff in between weekly

services. Best dandruff defense when used in conjunction with KeraCare Dry & Itchy Scalp

Moisturizing Shampoo and Conditioner.

l

INGREDIENTS AND APPEARANCE

KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63766-004
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM BORATE (UNII: 91MBZ8H3QO)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SAFFLOWER OIL (UNII: 65UEH262IS)
CLOVE (UNII: K48IKT5321)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHOL (UNII: L7T10EIP3A)
SULFUR (UNII: 70FD1KFU70)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63766-004-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	06/18/2009
2	NDC: 63766-004-02	7.5 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(63766-004)