Label: H2 365 CLEAN- glycerin soap

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 16, 2019

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

  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    coconut oil powder, silver, raisinseed oil, avocado oil, plumseed oil

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply to the skin and wash away with clean water

  • WARNINGS

    do not use if yu have skin problems

    if red spots, swelling or itching occur during use, discontinue use

    if gets in your eyes, wash with clean water

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    H2 365 CLEAN 
    glycerin soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73269-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73269-0001-170 g in 1 PACKAGE; Type 0: Not a Combination Product09/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/14/2019
    Labeler - IRISTA (689523945)
    Registrant - IRISTA (689523945)
    Establishment
    NameAddressID/FEIBusiness Operations
    IRISTA689523945manufacture(73269-0001) , label(73269-0001)