Label: HAND SANITIZER EARTHZEN- hand saniziter earthzen gel

  • 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 August 12, 2020

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  • ACTIVE INGRIDIENT

    ETHYL ALCOHOL 70%

  • PURPOSE

    ANTISEPTIC

  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS AND LAST. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

  • WARNING

    WARNINGS: FLAMMABLE KEEP AWAY FROM HEAT OR FLAME. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE YES. IN CASE OF CONTACT RINSE EYE THRROUGHLY WITH WATER

    DO NOT USE ON CHILDREN LESS THAN 2 MONTHS OF AGE. OPEN SKIN WOUNDS AVOID CONTACT WIITH BROKER SKIN

  • DIRECTIONS

    PLACE ENOUGH PRODUCTO NO HANDS TO COVER ALL SUFACES. RUB HANDS TOGETHER UNTIL DRY.

    SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING

    OTHER INFORMATION: STORE BETWEEN 15-30C. AVOID FREEZING AND EXCESSIVE HEAT ABOCE 40C

    MAY DISCOLOR CERTAIN FABRIC OR SUFACES

  • INACTIVE

    WATER, CARBOMER PROPANEDIOL AMINOMETHYL PROPANOL PEG 40 HYDROGENATED CASTOR OIL GLYCERIN

  • WARNING

    WARNING FLAMMABLE KEEP AWAY FROM HEAT

  • DOSAGE

    PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACE

  • KEEP OUT OF REACH

    KEEP OUT OF REACH OF CHILDREN

  • PACKAGE

    EARTH42955-011-01

    42955-011-02

    42955-011-03

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER EARTHZEN 
    hand saniziter earthzen gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42955-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.22 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.9 mL  in 100 mL
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.14 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.001 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.51 mL  in 100 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.33 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42955-011-0152 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
    2NDC:42955-011-031.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product08/12/2020
    3NDC:42955-011-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/12/2020
    Labeler - PROBEMEX S.A. DE CV (813566395)
    Registrant - PROBEMEX S.A. DE CV (813566395)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROBEMEX S.A. DE CV813566395manufacture(42955-011)
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