Label: MICONAZOLE NITRATE cream
- NDC Code(s): 68071-2657-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 51672-2001
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- 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
- not effective on the scalp or nails
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL -
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-2657(NDC:51672-2001) 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-2657-3 1 in 1 CARTON 03/15/2022 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/01/1991 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-2657)
