KERACARE- menthol 1% gel

KERACARE by

Drug Labeling and Warnings

KERACARE by is a Otc medication manufactured, distributed, or labeled by Avlon Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.00%

PURPOSE

Topical analgesic

USE

for the temporary relief of itching associated with minor skin irritations of the scalp.

WARNINGS

for external use only

When using this product

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

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults: Apply to scalp at least twice per week. Use daily for maximum results. Children: Consult a physician.

INACTIVE INGREDIENTS

Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Paraffin, Polyethylene, Salicylic Acid, Tocopheryl Acetate, Fragrance/Parfum, BHT, Sulfur, Butylphenyl Methylpropional, Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Cinnamyl Alcohol, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Limonene, Linalool, CI 26100.

PRINCIPAL DISPLAY PANEL

63766-001-01
110g

63766-001-02

200g

INGREDIENTS AND APPEARANCE

KERACARE 
menthol 1% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63766-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SALICYLIC ACID (UNII: O414PZ4LPZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SULFUR (UNII: 70FD1KFU70)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOEUGENOL (UNII: 5M0MWY797U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
D&C RED NO. 17 (UNII: ND733RX3JN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63766-001-02	200 g in 1 CANISTER; Type 0: Not a Combination Product	04/06/2014
2	NDC: 63766-001-01	110 g in 1 CANISTER; Type 0: Not a Combination Product	04/06/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/06/2014

Labeler - Avlon Industries, Inc. (121278626)

Establishment
Name	Address	ID/FEI	Business Operations
Avlon Industries, Inc.		121278626	manufacture(63766-001)