Label: BUFFERIN HAND SANITIZER- 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 15, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin when water, soap & towel are not available
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product

    • Keep out of eyes. In case of contact with eyes, rinse thoroughly with water
    • Do not use on broken or irritated skin.

    Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

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

  • Directions

    • Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.
  • Other information

    • Do not store above 105 °F (40 °C).
    • May discolor certain fabrics and wood surfaces.
  • Inactive ingredients

    water, carbomer, triethanolamine, fragrance, propylene glycol, glycerin, aloe barbadensis extract, tocopheryl acetate.

  • Questions?

    Call toll free 1-877-994-3666 Monday to Friday, 8am to 6pm, Central time

  • SPL UNCLASSIFIED SECTION

    Distributed by: Genomma Lab USA
    Inc., Houston, TX, 77027

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    The Science
    of Healthy Hands

    70% ETHYL ALCOHOL
    SOURCED IN THE USA

    BUFFERIN®
    HAND SANITIZER

    Antibacterial Gel

    KILLS 99.99%
    OF BACTERIA

    enriched with
    Vitamin E & Aloe

    8 fl oz
    (236 ml)

    2000009663
    S-20N092

    Principal Display Panel - 236 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    BUFFERIN HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-608
    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
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-608-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2020
    2NDC:50066-608-0270 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/12/2020
    Labeler - Genomma Lab USA (832323534)
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