Label: ANTI FUNGAL- coltrimazole liquid

  • NDC Code(s): 71582-001-10
  • Packager: Guangzhou Ertiantang Pharmaceutical Co.,Ltd
  • 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 August 23, 2017

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

  • Active Ingredients

    Clotrimazole  1%

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  • Purpose

    Coltrimazole 1%       Antifungal

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  • Uses

    • For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).
    • For relief of itching, scaling, burning and discomfort that accompany these conditions.

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  • Warnings

    For External Use Only.

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  • Do Not Use

    On children under 2 years of age unless directed by a doctor.

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  • Stop Use and Ask a Doctor if

    • Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot).
    • If irritation occurs or if there is no improvement within 4 weeks (for jock itch).
    • If condition persists longer, consult a doctor.

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  • When Use This Product

    • Avoid contact with the eyes.
    • This product is not effective on the scalp or nails.

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  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

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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 doctor. 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.

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  • Storage

    Store in cool, dry place away from direct sunlight.

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  • Inactive Ingredients

    GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK,PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLE

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Bluebird Health Company
    3856 Walnut Grove Avenue
    Rosemead, CA 91770-1655
    Phone: (626)677-1558

    Made in China

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  • Drug Facts
  • INGREDIENTS AND APPEARANCE
    ANTI FUNGAL 
    coltrimazole liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71582-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACETIC ACID (UNII: Q40Q9N063P)  
    GARLIC OIL (UNII: 4WG8U28833)  
    OSTHOL (UNII: XH1TI1759C)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)  
    PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)  
    PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71582-001-10 1 in 1 CARTON 09/22/2017
    1 300 mL in 1 PACKAGE; 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 09/22/2017
    Labeler - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
    Registrant - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
    Establishment
    Name Address ID/FEI Business Operations
    Guangzhou Ertiantang Pharmaceutical Co.,Ltd 546747036 manufacture(71582-001)
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