Label: ZEASORB AF- miconazole nitrate powder
Contains inactivated NDC Code(s)
NDC Code(s): 54868-5876-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0145-1506
- 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.
Updated May 23, 2012
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- Active ingredient
- Use (Athlete's Foot)
For external use only
Do not use
- on children under 2 years of age unless directed by a doctor.
Avoid contact with the eyes.
Stop use and ask a doctor if (Athlete's Foot)
- irritation occurs or there is no improvement within 4 weeks.
Directions (Athlete's Foot)
- 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.
- Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- Use daily for 4 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
call 1-888-438-7426. Side effects should be reported to this number.
Manufactured for: Stiefel Laboratories, Inc. Research Triangle Park, NC 27709
IRONMAN® is a registered trademark of World Triathlon Corporation used herein by permission.
ZEASORB is a registered trademark of Stiefel Laboratories, Inc.
Additional barcode labeling by:
Physicians Total Care, inc.
Tulsa, Oklahoma 74146
- Principal Display Panel
INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5876(NDC:0145-1506) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20.6 mg in 1 g Inactive Ingredients Ingredient Name Strength ACRYLAMIDE (UNII: 20R035KLCI) ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5876-0 71 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/31/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel