Major Clotrimazole

Manufacturer: Major Pharmaceuticals
Effective date: 2024-11-12
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 20:49:37

Label at a glance#

ProductMajor Clotrimazole

Active ingredientCLOTRIMAZOLE

Label structure11 sections

Indications and uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 week...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

Uses

INDICATIONS & USAGE SECTION

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with eyes.
If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area and dry thoroughly.
Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
Supervise children in the use of this product.
For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
If conditions persists longer, consult a doctor.
This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 15°-30°C (59°-86°F).
Close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100431

Principal Display Panel – 1 oz. Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^® NDC 0904-7822-31

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

Cures Most Athlete's Foot NET WT. 28.35 g (1 oz)

Principal Display Panel – 1 oz. Tube

Principal Display Panel – 1 oz. Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^® NDC 0904-7822-31

Cures Most

Athlete's Foot

Relieves Itching, Burning, Greaseless, Nonstaining

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

*Compare To the active ingredient in Lotrimin-AF® NET WT. 28.35 g (1 oz)

Principal Display Panel – 1 oz. Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7822	MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [MAJOR PHARMACEUTICALS]	4	Legacy NDC	20241114_7aa3e2eb-64c0-4585-8b80-7dc96c36fc1f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7822-31	GM - Gram	0904-7822	4550ddd1-4c27-45ac-a609-7e213f99b252	1	2013-08-02
0904-7822-36	GM - Gram	0904-7822	fbe6bade-1447-4324-b21c-27f87754c0b2	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Major Clotrimazole
CLOTRIMAZOLE
WATER
CETOSTEARYL ALCOHOL
POLYSORBATE 60
BENZYL ALCOHOL
SORBITAN MONOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
OCTYLDODECANOL
CETYL PALMITATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-7822	0904-7822-31, 0904-7822-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOTRIMAZOLE	G07GZ97H65	ACTIB
WATER	059QF0KO0R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
OCTYLDODECANOL	461N1O614Y	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT

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 · 99 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL PALMITATE	CETYL PALMITATE	5ZA2S6B08X	CREAM / TOPICAL	0.32 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	AEROSOL, FOAM / TOPICAL		30 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRACAVITARY	0.01 ml		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / VAGINAL	0.03 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	GEL / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRA-ARTICULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / ORAL	62.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET, DELAYED RELEASE / ORAL	2.31 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SPRAY / TOPICAL	4.58 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	LOTION / TOPICAL		89 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / RECTAL		124 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / VAGINAL	13.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CETYL PALMITATE	CETYL PALMITATE	5ZA2S6B08X	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM, EXTENDED RELEASE / TRANSDERMAL	253.4 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	TABLET / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	AEROSOL, FOAM / TOPICAL	0.55 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / TOPICAL		177 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM / TRANSDERMAL	32.44 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	EMULSION / ORAL	20 mg/1ml		Exact identifier — unii candidate 13 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
485b130f-21c2-6f45-e063-6394a90a2540			7aa3e2eb-64c0-4585-8b80-7dc96c36fc1f	2026-01-14	Warnings	Exact identifier spl set id: 7aa3e2eb-64c0-4585-8b80-7dc96c36fc1f

Reported adverse events (FAERS/openFDA)#

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