Label: LEADER MEDICATED- miconazole nitrate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-653-18 - Packager: Cardinal Health 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 October 31, 2012
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
- Keep out of reach of children
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Directions
- clean and dry affected area
- 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 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 persists, consult a doctor
- this product is not effective on scalp or nails
- Other infomation
- Inactive ingredients
- Questions
- Box Label
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INGREDIENTS AND APPEARANCE
LEADER MEDICATED
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-653 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE 1.42 g in 71 g Inactive Ingredients Ingredient Name Strength ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-653-18 71 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/31/2010 Labeler - Cardinal Health Inc. (097537435)