Label: ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 50090-2231-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0472-0735
- 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 August 23, 2018
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- Drug Facts
- Active ingredient
Miconazole nitrate, USP 2%Close
- proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
- for effective relief of itching, scaling, cracking, burning, and discomfort
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.
- wash 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
- if condition lasts longer, contact a doctor
- this product is not effective on the scalp or nails
- Other information
- store at controlled room temperature 59°-86°F (15°-30°C).
- before using any medication, read all label directions. Keep carton, it contains important information.
- Inactive ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified waterClose
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.Close
- HOW SUPPLIED
NDC: 50090-2231-0 14 g in a TUBE / 1 in a CARTONClose
- miconazole nitrate
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2231(NDC:0472-0735) 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 BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2231-0 1 in 1 CARTON 11/16/2015 1 14 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 06/01/1997 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-2231)