Label: ANTIFUNGAL CREAM- 2% miconazole nitrate cream cream
- NDC Code(s): 63517-009-04, 63517-009-05
- Packager: Cardinal Health, 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.
Updated November 12, 2020
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- For external use only
- Avoid contact with eyes
- Keep out of reach of children
- If swallowed, get medical help or contact Poison Control Center right away
- For athlete's foot and ringworm, if irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a physician
- For jock itch, if irritation occurs or there is no improvement within 2 weeks, discontinue use and consult a physician
- Do not use on deep or puncture wounds, animal bites, serious burns, for diaper rash, on children younger tha 2 years of age.
- Active Ingredients
- Glently cleanse the treatment area
- Pat dry
- Apply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physician
- For athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once daily
- Use daily for 4 weeks for treatment of athlete's foot and ringworm
- Use daily for 2 weeks for treamnet of jock itch
- If condition persists longer, consult a physician
- This product is not effective on the scalp or nails
Glently cleanse the treatment areaPat dryApply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physicianFor athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once dailyUse daily for 4 weeks for treatment of athlete's foot and ringwormUse daily for 2 weeks for treamnet of jock itchIf condition persists longer, consult a physicianThis product is not effective on the scalp or nails
- Other Information
- Keep out of reach of children
- Inactive Ingredients
INGREDIENTS AND APPEARANCE
2% miconazole nitrate cream cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-009 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 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE 1000 (UNII: MCU2324216) CETYL DIMETHICONE 45 (UNII: IK315POC44) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) PROPYLPARABEN (UNII: Z8IX2SC1OH) WHITE WAX (UNII: 7G1J5DA97F) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ZINC OXIDE (UNII: SOI2LOH54Z) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CUCUMBER FRUIT OIL (UNII: R81Y52NPCT) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63517-009-04 120 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2015 2 NDC:63517-009-05 5 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2015 Labeler - Cardinal Health, Inc. (961027315)