NDC | 53329-079-64 |
Set ID | 3afb78ad-af6e-47f6-b142-6cce45bd5e9e |
Category | HUMAN OTC DRUG LABEL |
Packager | Medline Industries, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active ingredient
- Purpose
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Use
- For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- For the treatment of superficial skin infections caused by yeast (Candida albicans)
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch.
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Warnings
For external use only
When using this product
- do not use on children under 2 years of age unless directed by a doctor
- avoid contact with the eyes.
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Directions
- Clean the affected area and dry thoroughly. Apply a layer of cream 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 socks at least once daily.
- For athlete’s foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
- Other information
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Inactive ingredients
Acrylates/Octylacrylamide Copolymer, Behenoxy Dimethicone, Ceteareth -6 (and) Stearyl Alcohol, Disodium EDTA, Myristyl Myristate, Polyglyceryl -3 Diisostearate, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben, Quaternium -15, Sodium Phosphate, Stearamidoethyl Diethylamine, Stearic Acid, Water, Xanthan Gum
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - Carrington
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INGREDIENTS AND APPEARANCE
CARRINGTON ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-079 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 STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) QUATERNIUM-15 (UNII: E40U03LEM0) SODIUM PHOSPHATE (UNII: SE337SVY37) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-079-64 141 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2007 Labeler - Medline Industries, Inc. (025460908)