Label: HYDROGEM AEASOAP- aloe vera extract soap

  • NDC Code(s): 83811-0002-1
  • Packager: H2 biohealthcare Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 19, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    aloe very extract

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Apply an appropriate amount to the skin and rub, and wash away with warm water

  • WARNINGS

    For topical use only

    ■ if irritation occurs please consult a doctor

    ■ Be careful not to swallow.

  • INACTIVE INGREDIENT

    Sodium Palm Canelate, Sodium Palmate, Refined Water, Palm Canel Acid, Palm Acid, Glycerin, Sodium Chloride, Teslasodium EDTA, Magnesium Hydride, Kaolin, jojoba seed oil, green tea catechin, olive oil, fragrance

  • DOSAGE & ADMINISTRATION

    For topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HYDROGEM AEASOAP 
    aloe vera extract soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83811-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83811-0002-1100 g in 1 PACKAGE; Type 0: Not a Combination Product11/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/2023
    Labeler - H2 biohealthcare Co.,Ltd (695269509)
    Registrant - H2 biohealthcare Co.,Ltd (695269509)
    Establishment
    NameAddressID/FEIBusiness Operations
    H2 biohealthcare Co.,Ltd695269509manufacture(83811-0002)