LOTRIMIN- clotrimazole cream 
Bayer HealthCare 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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Lotrimin ®Clotrimazole

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

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

Questions?

866-360-3226

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

Lotrimin AF 0963

LOTRIMIN ®AF

clotrimazole cream

ANTIFUNGAL

NET WT 12g (0.42 OZ)

LOTRIMIN 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0963
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)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White to Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0963-11 in 1 CARTON02/01/2002
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11523-0963-21 in 1 CARTON02/01/2002
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11523-0963-51 in 1 CARTON02/01/2002
312 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:11523-0963-71 in 1 CARTON02/01/2002
424 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/2002
Labeler - Bayer HealthCare LLC (112117283)

Revised: 9/2023
Document Id: 0554a76c-95cd-b100-e063-6294a90a14fb
Set id: da948ef3-3709-4bfc-9d17-f6f1ea325343
Version: 10
Effective Time: 20230914
 
Bayer HealthCare LLC