NDC | 54868-2471-0 |
Set ID | 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942 |
Category | HUMAN OTC DRUG LABEL |
Packager | Physicians Total Care, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
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.
-
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
-
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 -
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)