Label: ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 63187-885-15
- Packager: Proficient Rx LP
- 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 December 1, 2018
If you are a consumer or patient please visit this version.
- 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 onlyClose
- DO NOT USE
Do not use on children under 2 years of age unless directed by a doctor.Close
- When using this product
- avoid contact with the eyes
- 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
Keep out of reach of children. If swallowed, get medical help or contact a PoisonClose
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.
Distributed by: Actavis
Proficient Rx LP
Thousand Oaks, CA 91320Close
- Principal Display Panel
Compare to the active ingredient in Micatin® Antifungal Cream*
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning
Cures Most Athlete’s Foot, Jock Itch & Ringworm
Net wt. 0.5 oz (14g)Close
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-885(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:63187-885-15 1 in 1 CARTON 09/01/2017 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 05/01/2007 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079502574 RELABEL(63187-885)