Label: MICONAZOLE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-050-01 - Packager: Kinray, 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.
Drug Label Information
Updated June 22, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Warnings
- DO NOT USE
- STOP USE
- Uses
- Indications and Usage
- Other information.
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Directions
- 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.
- Foe athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on scalp or nails.
- Inactive Ingredients
- Keep Out of Reach of Children
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MICONAZOLE
miconazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-050 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-050-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 03/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/21/2013 Labeler - Kinray, Inc. (012574513) Registrant - Dynarex Corporation (008124539)