Label: SUNMARK ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 49348-689-72
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 4, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Miconazole nitrate 2%Close
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of
For external use only
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
This product is not effective on the scalp or nails.
For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- 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; change shoes and socks at least once dailyClose
- Other information
- To open: unscrew cap, use pointed end on cap to puncture seal
- store at room temperature
- see carton or tube crimp for lot number and expiration date
- Inactive ingredients
apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified waterClose
- SPL UNCLASSIFIED SECTION
Distributed by McKesson One Post StreetClose
San Francisco, CA 94104
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Miconazole Nitrate 2%
CURES MOST ATHLETE'S FOOT
NET WT 1 OZ (30 g)
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-689 Route of Administration TOPICAL DEA Schedule 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 apricot kernel oil (UNII: 54JB35T06A) benzoic acid (UNII: 8SKN0B0MIM) butylated hydroxytoluene (UNII: 1P9D0Z171K) glycol stearate (UNII: 0324G66D0E) mineral oil (UNII: T5L8T28FGP) polyethylene glycol 300 (UNII: 5655G9Y8AQ) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-689-72 1 in 1 CARTON 1 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 10/01/1991 Labeler - McKesson (177667227) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-689)