Label: ANTIFUNGAL BODY- miconazole nitrate cream
- NDC Code(s): 68599-0206-4
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
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 16, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses
- for treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- relieves itching,scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
- for treatment ofsuperficial skin infections caused by yeast (Candida albicans)
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WARNINGS
Warnings
- For External use only.
When using this product
- Do not get into eyes
Stop use and ask a doctor if
- irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch.
Do not use on
- children under 2 years of age unless directed by a doctor
- diaper rash
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Clean the affected area and dry thoroughly
- Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
- Supervise children in the use of this product
Athlete’s foot
- Pay special attention to the spaces between toes
- Wear well-fitting, ventilated shoes and change shoes and socksat least once daily
Athlete’s foot and ringworm
- Use daily for 4 weeks
Jock itch
- Use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on scalp or nails.
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INACTIVE INGREDIENT
Inactive ingredients
Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL BODY
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-0206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALANINE (UNII: OF5P57N2ZX) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE (UNII: V5VD430YW9) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LYSINE (UNII: K3Z4F929H6) ARGININE (UNII: 94ZLA3W45F) THREONINE (UNII: 2ZD004190S) PROLINE (UNII: 9DLQ4CIU6V) GLYCINE (UNII: TE7660XO1C) VALINE (UNII: HG18B9YRS7) METHIONINE (UNII: AE28F7PNPL) PHENYLALANINE (UNII: 47E5O17Y3R) CYSTEINE (UNII: K848JZ4886) DMDM HYDANTOIN (UNII: BYR0546TOW) LEUCINE (UNII: GMW67QNF9C) TYROSINE (UNII: 42HK56048U) TROLAMINE (UNII: 9O3K93S3TK) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ASPARTIC ACID (UNII: 30KYC7MIAI) SERINE (UNII: 452VLY9402) MALTODEXTRIN (UNII: 7CVR7L4A2D) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) HISTIDINE (UNII: 4QD397987E) GLUTAMIC ACID (UNII: 3KX376GY7L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PEG-100 STEARATE (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-0206-4 118 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/01/2017 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-0206)
