CLOTRIMAZOLE- clotrimazole cream 
Rebel Distributors Corp

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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Perrigo Clotrimazole Cream USP, 1% Drug Facts

Active ingredient

Clotrimazole 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 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, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions or comments?

1-800-719-9260

Principal Display Panel

Cures Most Athlete's Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

Clotrimazole 1%

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-030(NDC:45802-434)
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-030-151 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/03/2011
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 12/2011
Document Id: 706f3bb5-1ada-420a-9d8e-79aea018df53
Set id: 706f3bb5-1ada-420a-9d8e-79aea018df53
Version: 1
Effective Time: 20111227
 
Rebel Distributors Corp