KERACARE

Manufacturer: Avlon Industries, Inc.
Effective date: 2024-10-09
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:24:18

Label at a glance#

ProductKERACARE

Active ingredientMENTHOL

Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.00%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

for external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KeraCare Glossifier

Product NDC 63766-001

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039043	menthol 1 % Topical Gel	PSN	6
1039043	menthol 0.01 MG/MG Topical Gel	SCD	6
1039043	menthol 1 % Topical Gel	SY	6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63766-001-01	2024-02-29	C162847	48780-1	1030e365-60ea-111a-e063-dadaa90a10e2	KeraCare Dry & Itchy Scalp Glossifier
63766-001-02	2024-02-29	C162847	48780-1	1030e365-60ea-111a-e063-dadaa90a10e2	KeraCare Dry & Itchy Scalp Glossifier
63766-001-01	2024-01-30	C162847	48780-1	1030e365-60ea-111a-e063-dadaa90a10e2	KeraCare Dry & Itchy Scalp Glossifier
63766-001-02	2024-01-30	C162847	48780-1	1030e365-60ea-111a-e063-dadaa90a10e2	KeraCare Dry & Itchy Scalp Glossifier

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63766-001-01	KERACARE	110 g in 1 CANISTER	GEL	110		6
63766-001-02	KERACARE	200 g in 1 CANISTER	GEL	200		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63766-001	KERACARE (MENTHOL 1%) GEL [AVLON INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20241012_f72eec6d-1204-4e03-8aed-d5bcf8d3bbce.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	1
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
BUTYLPHENYL METHYLPROPIONAL	INACTIVE INGREDIENT	T7540GJV69	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
CINNAMYL ALCOHOL	INACTIVE INGREDIENT	SS8YOP444F	1
D&C RED NO. 17	INACTIVE INGREDIENT	ND733RX3JN	1
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYDROXYCITRONELLAL	INACTIVE INGREDIENT	8SQ0VA4YUR	1
ISOEUGENOL	INACTIVE INGREDIENT	5M0MWY797U	1
ISOMETHYL-.ALPHA.-IONONE	INACTIVE INGREDIENT	9XP4LC555B	1
LIMONENE, (+/-)-	INACTIVE INGREDIENT	9MC3I34447	1
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SULFUR	INACTIVE INGREDIENT	70FD1KFU70	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

KERACARE
Menthol 1%
PETROLATUM
SUNFLOWER OIL
CASTOR OIL
PARAFFIN
HIGH DENSITY POLYETHYLENE
SALICYLIC ACID
.ALPHA.-TOCOPHEROL ACETATE
BUTYLATED HYDROXYTOLUENE
SULFUR
OLIVE OIL
ISOMETHYL-.ALPHA.-IONONE
.ALPHA.-AMYLCINNAMALDEHYDE
BENZYL SALICYLATE
EUGENOL
GERANIOL
HYDROXYCITRONELLAL
ISOEUGENOL
LIMONENE, (+/-)-
LINALOOL, (+/-)-
D&C RED NO. 17
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63766-001	63766-001-02, 63766-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
CASTOR OIL	D5340Y2I9G	IACT
PARAFFIN	I9O0E3H2ZE	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
SULFUR	70FD1KFU70	IACT
OLIVE OIL	6UYK2W1W1E	IACT
ISOMETHYL-.ALPHA.-IONONE	9XP4LC555B	IACT
.ALPHA.-AMYLCINNAMALDEHYDE	WC51CA3418	IACT
BENZYL SALICYLATE	WAO5MNK9TU	IACT
EUGENOL	3T8H1794QW	IACT
GERANIOL	L837108USY	IACT
HYDROXYCITRONELLAL	8SQ0VA4YUR	IACT
ISOEUGENOL	5M0MWY797U	IACT
LIMONENE, (+/-)-	9MC3I34447	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
D&C RED NO. 17	ND733RX3JN	IACT
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 66 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii+route 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii+route 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 27 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier ndc (package): 63766-001-02 ndc (package): 63766-001-01 ndc (product): 63766-001 ndc11 (package): 63766000101 ndc11 (package): 63766000102 spl id: 2413c890-1c9f-cfe9-e063-6394a90a1927 spl set id: f72eec6d-1204-4e03-8aed-d5bcf8d3bbce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.