Your browser does not support JavaScript! LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]
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LOTRIMIN ANTIFUNGAL (miconazole nitrate) powder
[MSD Consumer care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, cracking, burning and scaling

Warnings

For external use only

Avoid contact with the eyes

Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Do not use on children under 2 years of age unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • sprinkle a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

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

© Copyright & Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 90g Can Label

NDC 11523-0919-1

LOTRIMIN®AF
ANTIFUNGAL
miconazole nitrate

Cures Most
Athlete's Foot

POWDER

Absorbs Moisture
Relieves Itching,
Burning & Scaling

NET WT 90g (3 OZ)

37871-00

Principal Display Panel - 90g Can Label
LOTRIMIN   ANTIFUNGAL
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-0919
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole nitrate (Miconazole) Miconazole nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzethonium chloride 
starch, corn 
kaolin 
sodium bicarbonate 
zinc oxide 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/01/1993
Labeler - MSD Consumer care, Inc. (968091715)

Revised: 2/2013
 
MSD Consumer care, Inc.

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