Label: MICONAZOLE NITRATE cream
- NDC Code(s): 70403-924-30
- Packager: Aru Pharma Inc.
- 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 May 15, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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 persist • 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
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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 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
- Inactive ingredients
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70403-924 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CHLOROCRESOL (UNII: 36W53O7109) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (white to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70403-924-30 1 in 1 CARTON 01/01/2018 03/31/2025 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 01/01/2018 03/31/2025 Labeler - Aru Pharma Inc. (079736192)