Label: SANI-CHOICE INSTANT 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 September 4, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol- 70%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use- To Sanitize hands without water or rinse

  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame. 

    ■ Keep out of eyes. ■ In case of contact with eyes, flush thoroughly with water ■ Do not inhale or ingest.

    If ingested, seek medical help or contact a Poison Control Center right away.

    Discontinue if skin irritation or redness occurs

    ■ Keep away from children 

  • Directions

    Apply Gel to hands; Rub thoroughly; Allow to dry without wiping or rinsing. Store at room temperature

  • Inactive Ingredients

    Water, Acrylic Copolomer, Glycerin, Fragrance, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

    FOR ANTISEPTIC USE

    Distributed By

    Sani- Choice Corporation

    4000 West 6th St. Suite B-208

    Lawrence, Kansas 66049

    MADE IN USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SANI-CHOICE INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80412-070
    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)  
    ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) (UNII: 3K8D4YRM4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80412-070-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/04/2020
    Labeler - SANI-CHOICE CORPORATION (117632085)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANI-CHOICE CORPORATION117632085manufacture(80412-070)
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