Label: SANI CHOICE INSTANT HAND SANITIZER- isopropyl 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 December 23, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol - 70%

  • Purpose

    Antiseptic

  • 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

    KILLS 99.9 % OF GERMS

    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 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80412-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL 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:80412-270-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/23/2020
    Labeler - SANI-CHOICE CORPORATION (117632085)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANI-CHOICE CORPORATION117632085manufacture(80412-270)
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