Clotrimazole by TRIFECTA PHARMACEUTICALS USA LLC / Trifecta Pharmaceuticals USA CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by TRIFECTA PHARMACEUTICALS USA LLC, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

KEEP OUT OF REACH OF CHILDREN

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 right away.

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.

Directions

• Wash 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. 

Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Other Information

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

Questions?

Adverse drug event call 1-888-296-9067
Dist. By Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LAURETH-23 (UNII: N72LMW566G)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-001-20	1 in 1 BOX	07/28/2015
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-001-05	1 in 1 BOX	08/23/2016
2		15 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	03/10/2015

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)