Label: ALL G ESSENTIALS HAND SANITIZER- ethyl 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 June 4, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses: To reduce microbes on the skin that could cause disease. Recommended for repeated use.

  • WARNINGS

    Warnings: For external use only on hands.
    Flammable, keep away from fire or flame.
    When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
    Stop use and ask a doctor if: Irritation or redness develops, condition persists for more than 72 hours.

    Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • STORAGE AND HANDLING

    Other Information: Do not store above 105F. May discolor some fabrics. Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Ethyl Alcohol, Water, Glycerin, Hydrogen Peroxide, Carbopol, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    KILLS 99.99% OF ILLNESS-CAUSING GERMS

    EXTRA STRONG 70% Ethyl Alcohol

    Manufactured for Global Products Group LLC by Aggrist, Inc.
    PO Box 749, Oakboro, NC 28129 (Mailing) 129 S. Main St.,
    Oakboro, NC 28129 (Shipping) 28129 888-871-2341

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ALL G ESSENTIALS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78285-175
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78285-175-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - AGGRIST INC (117525445)
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