Label: MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69771-041-25 - Packager: GERI-GENTLE CORPORATION
- 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 August 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
- DO NOT USE
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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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 healthcare professional • Supervise children in the use of this product.
For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.
For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.
This product is not effective on the scalp or nails.
- Other Information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69771-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) PEG-100 STEARATE (UNII: YD01N1999R) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CHLOROCRESOL (UNII: 36W53O7109) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) IMIDUREA (UNII: M629807ATL) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PETROLATUM (UNII: 4T6H12BN9U) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69771-041-25 113 g in 1 TUBE; Type 0: Not a Combination Product 08/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/22/2016 Labeler - GERI-GENTLE CORPORATION (080367686)