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.

Stop Use and ask a Doctor

Irritation occurs

There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

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

Cetamacragol 1000, Cetostearyl alcohol, mineral oil, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum.

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

Made in India

www.trifecta-pharma.com

Globe Clotrimazole Anti-Fungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin AF.

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-087
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
CETETH-20 (UNII: I835H2IHHX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-087-01	1 in 1 BOX	06/04/2022
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-087-55	5 in 1 BOX	04/08/2022
2		28.4 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 Drug	M017	04/08/2022

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)