Label: MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 77338-041-25
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- 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
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-041 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:77338-041-25 113 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 Drug M005 03/22/2016 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295) Establishment Name Address ID/FEI Business Operations ASTONEA LABS PRIVATE LIMITED 878533295 manufacture(77338-041)