Label: MICONAZOLE NITRATE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-2471-0 - Packager: Physicians Total Care, Inc.
- 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.
Drug Label Information
Updated November 5, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- clean 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
- this product does not work on the scalp or nails
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 every day
For athlete’s foot and ringworm
- use every day for 4 weeks
For jock itch
- use every day for 2 weeks. If condition lasts longer, contact a doctor.
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OTHER INFORMATION
Store at room temperature 59º - 86ºF (15º - 30ºC).
IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.
TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.
- INACTIVE INGREDIENTS
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 54868-2471-0
Compare to the active ingredient in Micatin® Antifungal Cream*
Actavis
Antifungal Cream
Miconazole Nitrate 2%
Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm
Net wt. 14 g tube cream
07350200D1 VC106266
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2471(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) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-2471-0 1 in 1 CARTON 1 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 03/20/2012 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-2471)