RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM- clotrimazole cream 
Rugby Laboratories

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Clotrimazole cream USP, 1%

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

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

For external use only

● Do not use on children under 2 years of age unless directed by a doctor.

● Avoid contact with eyes.

Directions

● 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.

Stop Use and ask a doctor if

Inactive Ingredients

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

Other Information

Other Information

Clotrimazole Antifungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin®AF.

Questions

Keep carton for complete Drug Facts

Call 1-800-645-2158

Distributed by:

RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in China

Packaging and Label

370816 RUGBY CLOTRIMAZOLE CREAM 1 PERCENT 1.6OZ 011722 CDER

371174 RUGBY CLOTRIMAZOLE CREAM 1 percent 1OZ REV1023 110223 CDER

Package Label

371175 RUGBY CLOTRIMAZOLE CREAM 1 percent 0.5OZ REV1023 110623 CDER

RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1265-261 in 1 BOX03/19/2020
145 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0536-1265-951 in 1 BOX11/20/2023
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0536-1265-111 in 1 BOX11/20/2023
314.17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/19/2020
Labeler - Rugby Laboratories (079246066)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 2/2024
Document Id: 11591a76-66cc-0b6b-e063-6394a90a0da5
Set id: a1365bc7-b376-adca-e053-2a95a90acf19
Version: 4
Effective Time: 20240214
 
Rugby Laboratories