NDC | 72570-104-30 |
Set ID | c3e6ee54-1906-4734-99fd-26335314d55f |
Category | HUMAN OTC DRUG LABEL |
Packager | Delsam Pharma Llc |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Drug Facts
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Do not use on children less than 2 years of age unless directed by a doctor
When using this product avoid contact with eyes
Stop use and ask a doctor if • irritation occurs • condition persists
• there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.
- 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
• 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 daily
• For athlete's foot and ringworm: use daily for 4 weeks.
• For jock itch: use daily for 2 weeks
• not effective on the scalp or nails - Inactive ingredients
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72570-104 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CHLOROCRESOL (UNII: 36W53O7109) WATER (UNII: 059QF0KO0R) 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:72570-104-30 1 in 1 CARTON 09/25/2018 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 09/25/2018 Labeler - Delsam Pharma Llc (081369679)