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Thera (Zhejiang Jingwei Pharmaceutical Co., Ltd.)

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CREAM 28 g in 1 TUBE (55621-001-01) Label Information

Complete Thera Information

  • INACTIVE INGREDIENT

    Inactive Ingredients  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water


  • ACTIVE INGREDIENT

    Active Ingredient

    Hydrocortisone, USP 1%


  • PURPOSE

    Purpose

    Anti-itch


  • INDICATIONS & USAGE

    Uses - for temporary relief of itching associated with minor skin irritations,inflammation and rashes due to:

    - eczema           -insect bites          -poison ivy

    -poison oak      -poison sumac      -soaps

    -jewelry            -detergents            -cosmetics

    -psoriasis         -seborrheic dermatisis

    -for external genital, feminine and anal itching

    -other uses of this product should be only under the advice and supervision of a doctor



  • KEEP OUT OF REACH OF CHILDREN

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


  • WARNINGS

    Warnings
    for external use only


  • STOP USE

    Do not use

    -in genital area if you have a vaginal discharge. Consult a doctor

    -for the treatment of diaper rash. Consult a doctor

    Stop use and ask a doctor if

    -symptoms last for more than 7 days

    -the condition gets worse

    -symptoms clear up and then occur again within a few days

    -rectal bleeding occurs



  • WHEN USING

    When using this product

    -avoid contact with eyes

    -do not use more than directed unless directed by a doctor

    -do not put this product into the rectum by using fingers or any other mechanical device or applicator



  • DOSAGE & ADMINISTRATION

    Directions

    for itching of skin irritation, inflammation and rashes:

    -adults and children 2 years of age and older: apply to the affected areanot more than 3 to 4 times dailt

    -for children udner 2 years of age: ask a doctor

    for external anal and genital itching, adults:

    -clean the affected area with mild soap and warm water and rinse clean.

    -dry the affected area before applying

    -apply to the affected area not mroe than 3 to 4 times daily

    -children under 12 years of age: ask a doctor


  • INGREDIENTS AND APPEARANCE
    THERA  PLUS
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55621-001-01 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    Name Address ID/FEI Business Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd. 530876549 manufacture(55621-001)