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.

----------

Lotrimin ®

Antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

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 front label

Lotrimin AF powder back label

LOTRIMIN  ANTIFUNGAL
miconazole nitrate powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0919
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
STARCH, CORN (UNII: O8232NY3SJ)  
KAOLIN (UNII: 24H4NWX5CO)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Product Characteristics
Color white (White to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-0919-1 90 g in 1 CAN; Type 0: Not a Combination Product 09/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 09/01/1993
Labeler - Bayer HealthCare LLC (968091715)

Revised: 6/2016
Document Id: 35d06fcb-cead-2a64-e054-00144ff8d46c
Set id: cebd222c-074f-443c-bd37-612114b27bbd
Version: 3
Effective Time: 20160621
 
Bayer HealthCare LLC