Label: MICONOLE- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43645-112-45 - Packager: Option Labs
- Category: HUMAN OTC DRUG LABEL
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 August 15, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
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Directions
- 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 ringworm use daily for 4 weeks, if condition persists longer, consult a doctor
- this product is not effective on the scalp or nails.
- Other Information
- Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MICONOLE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43645-112 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43645-112-45 1 in 1 CARTON 1 42.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/15/2013 Labeler - Option Labs (078380329) Registrant - Option Labs (078380329)