NDC | 70403-924-30 |
Set ID | 0eecb20d-49bc-4186-ac29-f839536b5de2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Aru Pharma Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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 persist • 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
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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
- 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:70403-924 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:70403-924-30 1 in 1 CARTON 01/01/2018 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 01/01/2018 Labeler - Aru Pharma Inc. (079736192)