CLOTRIMAZOLE- clotrimazole cream 
Delsam Pharma Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CLOTRIMAZOLE CREAM USP 1%

Drug Facts

Active ingredient

Clotrimazole USP 1%

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch and ringworm

• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

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

When using this product avoid contact with the eyes 

Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• wash the affected area and dry thoroughly

• apply a thin layer over affected area twice daily (morning and night)

• 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 condition persists longer, consult a doctor • this product is not effective on the scalp or nails

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water.

Other information

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

• store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

Compared to the active ingredient in Lotrimin AF

ANTIFUNGAL

Cures Most Athlete's Foot

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

image description

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CHLOROCRESOL (UNII: 36W53O7109)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72570-105-301 in 1 CARTON09/25/201803/15/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/25/201803/15/2023
Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023
 
Delsam Pharma Llc