TINEACIDE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [BLAINE LABS INC.]

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TINEACIDE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [BLAINE LABS INC.]
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NDC 63347-502-01
Set ID e5e842ac-8a39-4686-b7b9-0a3d87791e2d
Category HUMAN OTC DRUG LABEL
Packager Blaine Labs Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active Ingredient

    Drug Facts

    Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • 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.

  • 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.
  • Warnings

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

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

  • 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).

  • 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.
  • 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)
  • 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.

  • 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

    res

  • INGREDIENTS AND APPEARANCE
    TINEACIDE  ANTIFUNGAL
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.7 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CLOTRIMAZOLE (UNII: G07GZ97H65)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-502-0135 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2013
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-502)
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