Label: HAND SANITIZER GEL- alcohol gel gel

  • 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 March 25, 2020

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  • DESCRIPTION

    Hand Sanitizer Gel

    Moisturizing with Aloe

    Effective at eliminating more than 99.9% of many common harmful germs & bacteria in as little as 15 seconds.

  • ACTIVE INGREDIENT

    Active ingredient

    Isopropyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    Hand sanitizer to help reduce bacteria on the skin that could cause disease.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only

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

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry.

    No rinsing required.

    No towels needed .

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer

  • OTHER SAFETY INFORMATION

    Other information

    Do not store above 110°F (43°C)  May discolor certain fabrics or surfaces

  • SPL UNCLASSIFIED SECTION

    Manufactured By: AgroChem, Inc 26 Freedom Way Saratoga Springs, NY 12866

  • PRINCIPAL DISPLAY PANEL

    New

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    alcohol gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17307-1110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17307-1110-1470 mL in 1 CONTAINER; Type 0: Not a Combination Product03/24/2020
    2NDC:17307-1110-2940 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/24/2020
    3NDC:17307-1110-33780 mL in 1 JUG; Type 0: Not a Combination Product03/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/24/2020
    Labeler - AgroChem Inc (805427700)
    Registrant - AgroChem Inc (805427700)
    Establishment
    NameAddressID/FEIBusiness Operations
    AgroChem Inc805427700manufacture(17307-1110)
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