Label: THERA PLUS- hydrocortisone cream

  • NDC Code(s): 55621-001-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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

  • INACTIVE INGREDIENT

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Hydrocortisone, USP 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

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

    - 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

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    THERA   PLUS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-001-0128 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 DrugM01703/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-001)