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

Drug Label Information

Updated December 15, 2023

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

  • Active Ingredients

    Clotrimazole  1%

  • Purpose

    Coltrimazole 1%       Antifungal

  • 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.

  • Warnings

    For External Use Only.

  • Do Not Use

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

  • 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.

  • When Use This Product

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

  • Keep Out of Reach of Children

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

  • 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.

  • Storage

    Store in cool, dry place away from direct sunlight.

  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:

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

    Made in China

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI FUNGAL 
    coltrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71582-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71582-001-101 in 1 CARTON09/22/2017
    1300 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/22/2017
    Labeler - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
    Registrant - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ertiantang Pharmaceutical Co.,Ltd546747036manufacture(71582-001)