Label: MICONAZOLE NITRATE CREAM 2%- miconazole nitrate cream
- NDC Code(s): 68071-2978-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 79503-106
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 17, 2023
If you are a consumer or patient please visit this version.
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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:68071-2978(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:68071-2978-3 1 in 1 CARTON 04/17/2023 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 08/19/2021 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-2978)
