Label: TINEACIDE ANTIFUNGAL- miconazole nitrate cream 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Drug Facts

    Active Ingredient

    Miconazole Nitrate 2%

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  • Purpose

    Antifungal

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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Uses

    • Cures most athlete's foot (tinea pedis).
    • Cures most jock inch (tinea cruris) and ring worm (tinea corporis).
    • Relieves itching, burning, cracking, and scaling which accompany these conditions.
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  • Warnings

    • For external use only.
    • Do not use in or near the mouth or eyes.
    • Do not use for vaginal yeast infections.
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  • When using this product,

    do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

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  • Stop use and consult a physician 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).

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  • Directions

    • Adult and children 2 years and older. Children under 2 years: ask physician.
    • Wash the affected area with soap and water and dry thoroughly before applying.
    • For athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 4 weeks (morning and night), or as directed by a physician.Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
    • For jock itch and ringworm apply twice daily to affected skin for 2 weeks or as directed by a physician. This product is not effective on the scalp or mails.
    • Wash hands after each use.
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  • Other Information

    • Do not use if seal on bottle is broken or is not visible.
    • Store between 2°  and 30°  C (36°  and 85°  F)
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  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, lavandula Angustifolia Lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.

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  • Product Label

    Dr. Blaine's

    TINEACIDE®

    Antifungal Cream

    Kills the skin fungus that causes fungal nails

    Treats mild to severe infections

    NET WT 1.25 OZ (35 g)

    5 FUNGUS FIGHTERS

    NEW and IMPROVED FORMULATION  100% MONEY-BACK GUARANTEE!

    Blaine TINEACIDE5021 Label

    BONUS: Easy-Grip, Heavy-Duty Nail Clipper!

    EXP.

    Proudly made in the U.S.A.!

    Please Recycle! This package is made from recyclable materials.

    Questions or Comments? Call (800) 307-8818 Monday-Friday 8:00AM and 5:00PM (EST)

    Blaine Labs Inc. Santa Fe Springs, CA 90670  www.DrBlaines.com  All rights reserved.

    Blaine TINEACIDE502 Label

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  • INGREDIENTS AND APPEARANCE
    TINEACIDE  ANTIFUNGAL
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63347-502
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 0.7 g  in 35 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    CLOTRIMAZOLE  
    COCO-CAPRYLATE/CAPRATE  
    EDETATE DISODIUM  
    GLYCERYL MONOSTEARATE  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)  
    LAVENDER OIL  
    METHYLPARABEN  
    PEG-100 STEARATE  
    POLYSORBATE 60  
    PROPYLPARABEN  
    STEARIC ACID  
    TEA TREE OIL  
    TROLAMINE  
    UREA  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63347-502-01 35 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/01/2013
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    Name Address ID/FEI Business Operations
    Blaine Labs Inc. 017314571 manufacture(63347-502)
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