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 November 22, 2019

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 finalpart333C09/22/2017
    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)