Label: ANTIFUNGAL CREAM- antifungal cream
- NDC Code(s): 68001-481-45, 68001-481-47, 68001-481-48
- Packager: BluePoint Laboratories
- 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 December 1, 2020
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- Active Ingredient
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- For the treatment of superficial skin infections caused by Yeast (Candida Albicans)
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
For external use only
Do not use:
- on children under 2 years of age unless directed by a doctor.
- avoid contact with eyes
- for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discotinue use and consult a doctor
- for jock itch- if irritation occurs, or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
- for diaper rash
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications and Usage
- Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- Dosage and Administration
- Keep Out Of Reach Of Children
- INACTIVE INGREDIENTS
- STORAGE AND HANDLING
- 2% Miconazole Nitrate Cream, USP Carton
- 2 % Miconazole Nitrate Cream, USP Tube Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68001-481 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LIGHT MINERAL OIL (UNII: N6K5787QVP) CHLOROCRESOL (UNII: 36W53O7109) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68001-481-45 1 in 1 CARTON 12/01/2020 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68001-481-47 1 in 1 CARTON 12/01/2020 2 42 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:68001-481-48 1 in 1 CARTON 12/01/2020 3 15 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 12/01/2020 Labeler - BluePoint Laboratories (985523874) Establishment Name Address ID/FEI Business Operations Gopaldas Visram & Co., Ltd 858030888 manufacture(68001-481)