CLOTRIMAZOLE- clotrimazole cream 
Chain Drug Consortium, 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-Antifungal

Drug Facts

Active ingredient

Clotrimazole, USP 1%

Purpose

Antifungal

Uses

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 ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN LOTRIMIN® AF*

Clotrimazole Cream, USP 1%
ANTIFUNGAL

Proven Clinically Effective in the Treatment of Most Athlete's Foot
Relieves: Itching ι Burning ι Cracking ι Scaling

NET WT 1 OZ (28g)

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CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-035
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-035-061 in 1 CARTON09/11/2003
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/11/2003
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 11/2022
Document Id: 5d6ad412-c7ee-445c-b802-3605a98269f9
Set id: a93b192d-e6c2-4024-84f5-241bdcd34f9a
Version: 9
Effective Time: 20221121
 
Chain Drug Consortium, LLC