Label: MICONAZOLE NITRATE cream
- NDC Code(s): 68071-3429-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69396-014
- 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 June 6, 2023
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- Drug Facts
- Active ingredient
- Purpose
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- Uses
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Warnings
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.
• irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).
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Directions
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.
• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.
Use daily for 4 weeks. If condition persists, consult a healthcare professional.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.
This product is not effective on the scalp or nails.
- INACTIVE INGREDIENT
- Other Information
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- Packaging
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3429(NDC:69396-014) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL DISTEARATE (UNII: 73071MW2KM) MINERAL OIL (UNII: T5L8T28FGP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3429-3 1 in 1 BOX 06/06/2023 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 03/22/2016 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-3429)
