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

TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH (MICONAZOLE NITRATE) CREAM [BLAINE LABS INC.]
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NDC 63347-503-01
Set ID b328a052-7456-4e34-b9ed-4c4219ff0451
Category HUMAN OTC DRUG LABEL
Packager Blaine Labs Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Miconazole Nitrate 2%

  • PURPOSE

    Purpose
    Antifungal

  • INDICATIONS & USAGE

    Uses
    • Cures most athlete’s foot (tinea pedis).
    • Cures most jock itch (tinea cruris) and ringworm (tinea corporis).
    • Relieves discomfort, irritation, cracking, scaly skin between the
       toes and itching, burning feet.

  • WARNINGS

    Warnings
    • Do not use on children under 2 years of age unless directed by a
       physician.
    • For external use only.
    • Do not use for vaginal yeast infections.
    • Avoid contact with the eyes. If eye contact occurs, rinse thoroughly
      with water.

    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),
    discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact

    the Poison Control Center right away at 800.222.1222

  • DOSAGE & ADMINISTRATION

    Directions
    • Wash the affected area with soap and water and dry thoroughly.
    • Apply a thin layer of the product over affected area twice daily
      (morning and night) or as directed by a physician.
      Supervise children in the use of this product.
    For athlete’s foot: Pay special attention to spaces between the
      toes; wear well-fitting, ventilated shoes, and change shoes and
      socks at least once daily.
    For athlete’s foot and ringworm: Use daily for 4 weeks; for jock
      itch, use daily for 2 weeks. If condition persists longer, consult
      a doctor.
    • This product is not effective on the scalp or nails.
    • Wash hands after each use.

  • OTHER SAFETY INFORMATION

    Other Information
    • Do not use if seal on bottle is broken or is not visible.
    • Store between 2˚ and 30˚ C (36˚ and 86˚ F).

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water (aqua), Cetyl Alcohol, PEG 100 Stearate, Glyceryl Stearate, Stearic
    Acid, Coco-Caprylate/Caprate, Polysorbate 60, Triethanolamine, Urea,
    Hydroxyethylcellulose, Disodium EDTA, Methylparaben, Propylparaben,
    Lavandula Angustifolia Lavender Oil, Tea Tree Oil, Clortrimazole, Aloe,
    Barbadensis Leaf Juice, Origanum Vulgare Leaf Oil (content carvacrol),
    Olea Europaea (Olive) Fruit Oil

  • Principal Display Package

    Dr. Blaine's®
    TINEACIDE+®
    ANTIFUNGAL CREAM

    MONEY BACK
    100%
    GUARANTEE

    Dr. Blaine's®
    TINEACIDE+®
    ANTIFUNGAL CREAM

    MAXIMUM
    STRENGTH
    FUNGUS TREATMENT

    1.25 OZ (36.9mg)

    6 16728 00004  0

    Dr. Robert Blaine developed
    Tineacide® Antifungal Cream in 1995
    because he suffered the loss of his
    foster father due to complications
    from diabetes and fungal foot
    infection. Dr. Blaine chose to
    devote his career to podiatry and proper
    foot care. 25 years later, Tineacide®
    has become synonymous with
    antifungal foot care products that
    actually work to kill foot fungus.

    To see Dr. Blaine’s full story, go to
    TINEACIDE.com

    Questions or Comments? Call 800.307.8818 Monday - Friday,
    8:00 AM and 5 PM (PST)
    All rights reserved. Made in the U.S.A.

    Please recycle.

    TINEACIDE+®
    ANTIFUNGAL CREAM

    ADVANCED
    FORMULATION
    NOW CONTAINING CARVACROL

    WILL ELIMINATE YOUR FOOT
    FUNGUS OR WE WILL REFUND YOUR
    MONEY IF IT DOESN’T WORK
    FOR YOU!

    • ELIMINATES ODORS

    • KILLS THE SKIN FUNGUS
       THAT CAUSES FUNGAL
       NAILS

    • TREATS MILD TO SEVERE
       INFECTIONS

    • MEDICAL GRADE
       ADVANCED FORMULA

    • 100% MONEY-BACK
       GUARANTEE!

    Manufactured by: Blaine Labs, Inc.
    11307 Lockport Place
    Santa Fe Springs, CA 90670
    800.307.8818 | www.TINEACIDE.com

    05001-01                        REV 20190326

    Tineacide 1.25 OZ Box

    Tineacide 1.25 OZ Bottle

    res

  • INGREDIENTS AND APPEARANCE
    TINEACIDE ANTIFUNGAL  MAXIMUM STRENGTH
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-503
    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
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CLOTRIMAZOLE (UNII: G07GZ97H65)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-503-011 in 1 BOX03/01/2019
    135 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2019
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-503)

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