Label: PRONATURE EARTH CONSCIOUS HAND SANITIZER WITH ALOE VERA EXTRACT- alcohol 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 November 2, 2021

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 69% v/v

  • Purpose

    Antibacterial Agent

  • Use

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only.

    Non Medical. Flammable. Keep away from fire or flame

    When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water

  • STOP USE

    Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

  • Directions

    • Place enough product in palm to thoroughly cover hands
    • Briskly rub hands together until dry
    • Children under 6 years of age should be supervised when using this product
  • Other Information

    Store below 104F (40C)

  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerin, PEG-40 Hydrogenated Caster Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Parfum

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PRONATURE EARTH CONSCIOUS HAND SANITIZER WITH ALOE VERA EXTRACT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73027-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73027-207-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    2NDC:73027-207-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    3NDC:73027-207-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    4NDC:73027-207-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - JIANGSU HANHE DAILY CHEMICALS CO., LTD. (414409758)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU HANHE DAILY CHEMICALS CO., LTD.414409758manufacture(73027-207)
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