Label: THERAPLUS PLUS- clotrimazole cream

  • NDC Code(s): 55621-003-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • INACTIVE INGREDIENT

    glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients

  • ACTIVE INGREDIENT

    Active Ingredient

    Clotrimazole 1%

  • WARNINGS

    Warnings

    For external use only

    Do not use

    on children under 2 years of age unless directed by a doctor

    on the scalp or nails

    When using this product

    avoid contact with eyes

  • PURPOSE

    Purpose

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    . If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

  • INDICATIONS & USAGE

      relieves itching, burning, cracking, scaling and discomfort associated with: Uses

    -athletes foot      -jock itch      -ring worm


  • DOSAGE & ADMINISTRATION

    Directions

    -wash and dry affected area thoroughly

    -apply a thin layer to affected area 2 times daily

    -for athlete's foot and ringworm, use daily for up to 4 weeks

    -for jock itch, use daily for up to 2 weeks

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    THERAPLUS   PLUS
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-003-0135 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-003)
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