Label: THE HYDRATOR, IONIC ALCOHOL- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 15, 2022

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  • Drug Facts

  • Active Ingredient (per 100ml)

    USP-grade Isopropyl Alcohol (99.98% concentration) 75ml

  • Purpose

    Antiseptic

  • Uses

    For effective sanitizing to reduce bacteria and provide deep hydration of skin, as well as to neutralize toxins on the face, hands and body

  • Warning

    For external use only
    Flammable, keep away from fire or flame.
    ▪ Keep out of eyes. For contact with eyes, flush thoroughly with water.

    Children should be supervised when using product.

  • Directions

    Apply to hands, face and body, rub vigorously into skin until product has evaporated.

  • Inactive Ingredients

    USP-grade  Sodium. Propionic Acid, Distilled Water

  • SPL UNCLASSIFIED SECTION

    100% Pharma-grade ingredients

    Patent Pending

    Super-charged antiseptic + deep hydration for the face, hands and body

    The Hydrator Ionic Alcohol is the first ionically-charged, hypoallergenic antiseptic. It delivers deep cell-level hydration and anti-microbial, anti-bacterial cleansing in a 13+ pH solution for the skin. Starting with 99.98% concentrated alcohol, we add Salionic™, which is an ionically charged, anti-microbial enhancement that optimizes the strength of the alcohol.

    G Water, LLC

    Waterford, MI 48329

    www.GWaterLLC.com

    Follow our QR Code to subscribe or contact us.

  • Packaging

    IMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    THE HYDRATOR, IONIC ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77960-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM (UNII: 9NEZ333N27)  
    PROPIONIC ACID (UNII: JHU490RVYR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77960-520-34100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    2NDC:77960-520-40120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    3NDC:77960-520-80240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - G WATER, LLC (117518218)
    Establishment
    NameAddressID/FEIBusiness Operations
    G WATER, LLC117518218manufacture(77960-520)
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