MAJOR CLOTRIMAZOLE- clotrimazole cream

Major Clotrimazole by

Drug Labeling and Warnings

Major Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

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.

Warnings

• 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.

• 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

• 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

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

Inactive ingredients

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

Questions?

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

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. Carton

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)

INGREDIENTS AND APPEARANCE

MAJOR CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7822
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL PALMITATE (UNII: 5ZA2S6B08X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7822-31	1 in 1 CARTON	10/04/2004
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0904-7822-36	1 in 1 CARTON	10/04/2004
2		14.17 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/04/2004

Labeler - Major Pharmaceuticals (191427277)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-7822)