KERACARE- menthol 1% gel 
Avlon Industries, Inc.

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KeraCare Dry & Itchy Scalp Glossifier

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, Olea Europaea (Olive) Fruit Oil, BHT, Sulfur, Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Limonene, Linalool, Red 17/CI 26100.

KeraCare Glossifier

Product NDC 63766-001

Label

KERACARE 
menthol 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63766-001-02200 g in 1 CANISTER; Type 0: Not a Combination Product04/06/2014
2NDC:63766-001-01110 g in 1 CANISTER; Type 0: Not a Combination Product04/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/06/2014
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIBusiness Operations
Avlon Industries, Inc.121278626manufacture(63766-001)

Revised: 2/2024
Document Id: 1285f611-7c31-1db7-e063-6394a90ac903
Set id: f72eec6d-1204-4e03-8aed-d5bcf8d3bbce
Version: 5
Effective Time: 20240229
 
Avlon Industries, Inc.