Label: MICONAZOLE NITRATE cream
- NDC Code(s): 68788-8107-2
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 61269-735
- 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 August 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- •
- clean the affected area and dry thoroughly
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- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
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- supervise children in the use of this product
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- for athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
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- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
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- if condition lasts longer, contact a doctor
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- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
Miconazole Nitrate Cream USP, 2%
Antifungal CreamNDC 68788-8107-2
*Compare to the active ingredient in
Micatin® Antifungal CreamSoothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven
Net wt. 1 oz (28 g)
H2 pharma
Relabeled By: Preferred Pharmaceuticals Inc.
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8107(NDC:61269-735) 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 BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8107-2 1 in 1 CARTON 11/03/2021 1 28 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 11/03/2021 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-8107)
