ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream 
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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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Antifungal cream
Clotrimazole Cream 1%

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

on children under 2 years, unless directed by a doctor.

When using this product

  • do not get into the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or 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

for athlete’s foot and ringworm

pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once every day. Use every day for 4 weeks for jock itch

use every day for 2 weeks. If condition lasts longer, contact a doctor.

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 (select option #2) between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Compare to the active
ingredient in Lotrimin® AF*
Premier Value®
Antifungal
CLOTRIMAZOLE CREAM 1%

NET WT 1 OZ (28 g)

premier antifungal label1

ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68016-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
OCTYLDODECYL STEARATE 
POLYSORBATE 60 
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-035-061 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/11/2003
Labeler - Premier Value (101668460)

Revised: 11/2013
Document Id: 099e9bb6-439f-406c-bf5f-1b09028e23ab
Set id: a93b192d-e6c2-4024-84f5-241bdcd34f9a
Version: 1
Effective Time: 20131113
 
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