Label: MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72071-101-21 - Packager: RTMH Enterprises DBA Research Technology Medical Home
- 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 December 28, 2022
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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.
Stop use and ask a healthcare professional if • 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
Clean the affected area and dry thoroughly • 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.
For athlete's foot: • 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.
For ringworm: 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.
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72071-101 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 PETROLATUM (UNII: 4T6H12BN9U) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72071-101-21 1 in 1 BOX 09/28/2018 1 15 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 09/28/2018 Labeler - RTMH Enterprises DBA Research Technology Medical Home (042580344) Registrant - RTMH Enterprises DBA Research Technology Medical Home (042580344)
