LOTRIMIN ANTIFUNGAL- miconazole nitrate powder 
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 ®

Antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

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
  • if 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

benzethonium chloride, corn starch, kaolin, sodium bicarbonate, starch/acrylates/acrylamide copolymer, zinc oxide

PRINCIPAL DISPLAY PANEL - 90g Can Label

NDC 11523-0919-1

LOTRIMIN®AF

ANTIFUNGAL

miconazole nitrate

Cures Most

Athlete's Foot

POWDER

NET WT 90g (3 OZ)

37871-00

Lotrimin AF Powder 0919 FrontLotrimin AF Powder 0919 Back

LOTRIMIN  ANTIFUNGAL
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0919
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
STARCH, CORN (UNII: O8232NY3SJ)  
KAOLIN (UNII: 24H4NWX5CO)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0919-190 g in 1 CAN; Type 0: Not a Combination Product09/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/01/1993
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2023
Document Id: 05549748-1162-52ef-e063-6394a90a12c9
Set id: cebd222c-074f-443c-bd37-612114b27bbd
Version: 7
Effective Time: 20230914
 
Bayer HealthCare LLC.