Label: MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 0536-1375-75
- Packager: Rugby
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 2024
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- Drug Facts
- Active ingredient
- Purpose
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- Uses
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Warnings
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
Do not use on children under 2 years of age unless directed by a doctor. When using this product 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) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
- Other information
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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 doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.
For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on the scalp or nails.
- INACTIVE INGREDIENT
- Other Information
- Packaging
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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:0536-1375 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) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) LAURETH-30 (UNII: W9D845551A) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) PETROLATUM (UNII: 4T6H12BN9U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1375-75 1 in 1 BOX 02/07/2023 1 28.3 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 Drug M005 02/07/2023 Labeler - Rugby (079246066) Registrant - Trifecta Pharmaceuticals USA (079424163)