CLOTRIMAZOLE- clotrimazole cream 
Premier Value

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.

----------

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®
NDC 68016-035-06 

Compare to the active
ingredient in Lotrimin® AF* 

Clotrimazole Cream USP 1%
Antifungal 

Cures Most Athlete’s Foot
Relieves Itching and Burning 

NET WT 1 OZ (28 g)

clotrimazole cream carton
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-035
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-035-06 1 in 1 CARTON
1 28 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 09/11/2003
Labeler - Premier Value (101668460)

Revised: 5/2015
Document Id: b35b4b44-1116-4913-8d65-7f57fcfd1ca6
Set id: a93b192d-e6c2-4024-84f5-241bdcd34f9a
Version: 2
Effective Time: 20150519
 
Premier Value