MICONAZOLE NITRATE- miconazole nitrate cream 
Taro Pharmaceuticals U.S.A., Inc.

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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Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole nitrate USP 2%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on children less than 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Cures Most Athlete's Foot

Antifungal Cream

Miconazole Nitrate
Cream USP, 2%
Antifungal Cream

NET WT 1/2 oz (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2001
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
apricot kernel oil (UNII: 54JB35T06A)  
benzoic acid (UNII: 8SKN0B0MIM)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
glycol stearate (UNII: 0324G66D0E)  
mineral oil (UNII: T5L8T28FGP)  
polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
water (UNII: 059QF0KO0R)  
PEG-6 stearate (UNII: 8LQC57C6B0)  
PEG-32 stearate (UNII: 33GX5WQC0M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2001-11 in 1 CARTON10/01/1991
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2001-21 in 1 CARTON10/01/1991
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C10/01/1991
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2001)

Revised: 1/2020
Document Id: 46fd39ef-5b7b-4c97-979f-c86cdf04b162
Set id: 7fd4037e-d350-47b7-a7d9-a43b8e366fa0
Version: 3
Effective Time: 20200130
 
Taro Pharmaceuticals U.S.A., Inc.