Label: MICONAZOLE NITRATE CREAM 2%- miconazole nitrate cream
- NDC Code(s): 79503-106-30
- Packager: Ezricare Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash
When using this product • avoid contact with the eyes
Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm
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Directions
• Clean the affected area and dry thoroughly. Apply a thin 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 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 • If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails
- Other information
- Inactive Ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Cures Most Athlete's Foot
Compared to the active ingredient in Micatin®*
Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin®
Distributed by:
EzriCare, LLC
Lakewood, NJ
www.EzriCare.com
Made in India
- Packaging
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE CREAM 2%
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79503-106 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) CHLOROCRESOL (UNII: 36W53O7109) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79503-106-30 1 in 1 CARTON 08/19/2021 07/01/2025 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 Drug M005 08/19/2021 07/01/2025 Labeler - Ezricare Llc (117573818)