Label: BLOOP ITCH SOOTHING TOPICAL- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • ACTIVE INGREDIENT

    Hydrocortisone 1%

  • PURPOSE

    Anti-itch

  • INDICATIONS & USAGE

    • Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • insect bites
    • seborrheic dermatitiss
    • psoriasis
    • Temporarily relieves external genital, feminine, and anal itching
    • Other uses of this product should only be under the advice and supervision of a doctor
  • WARNINGS

    For external use only.

    Do not use

    • in the genital area if you have genital itch associated with penile or vaginal discharge

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • condition worsens
    • condition does not improve within 7 days or bleeding persists beyond 7 days and do not begin use of any other hydrocortisone product.
  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    For itching or skin irritation, inflammation, and rashes:

    • Adults and children 12 years and older: apply to the affected area 3 to 4 times daily until symptoms resolve or for a maximum of two weeks.

    For external anal and genital itching adults:

    • gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • product may be applied to the skin of the anal canal with a clean finger
    • apply to affected area not more than 3 to 4 times daily
    • Children under 12 years of age consult a doctor
  • INACTIVE INGREDIENT

    Aloe barbadensis leaf extract, carapa guianensis seed oil, cetearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, dimethicone, disodium EDTA, ethylhexylglycerin, glycerin, methyl gluceth-20, orbignya oleifera seed oil, petrolatum, phenoxyethanol, polysorbate 60, potassium hydroxide, propanediol, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate, water

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    BLOOP ITCH SOOTHING TOPICAL 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83838-415
    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
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    BABASSU OIL (UNII: 8QSB4M5477)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83838-415-011 in 1 BOX11/14/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/14/2023
    Labeler - Three Nations Corp (119050054)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(83838-415)