NDC | 49348-689-72 |
Set ID | 7c15d95a-5b89-4789-8c91-3f61d7ec7707 |
Category | HUMAN OTC DRUG LABEL |
Packager | Strategic Sourcing Services LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
This product is not effective on the scalp or nails.
For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- 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
For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
-
INGREDIENTS AND APPEARANCE
SUNMARK MICONAZOLE NITRATE ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-689 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 apricot kernel oil (UNII: 54JB35T06A) benzoic acid (UNII: 8SKN0B0MIM) butylated hydroxytoluene (UNII: 1P9D0Z171K) glycol stearate (UNII: 0324G66D0E) mineral oil (UNII: T5L8T28FGP) polyethylene glycol 300 (UNII: 5655G9Y8AQ) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-689-72 1 in 1 CARTON 10/01/1991 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 10/01/1991 Labeler - Strategic Sourcing Services LLC (116956644)