Label: ANTIBACTERIAL- alcohol liquid

  • NDC Code(s): 0404-0122-01, 0404-0122-02
  • Packager: Henry Schein Inc.
  • 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 January 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin whenever soap and water is not readily available
    • helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
  • Warnings

    For external use only. Flammable, keep away from fire or flame

    Do not use

    • in the eyes, if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation or redness develop and 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

  • Directions

    • tear open packet and remove towelette
    • wipe hand, finger and wrist areas thoroughly with towelette for 15 seconds
    • dispose of used towelette properly
    • children under 6 years of age should be supervised when using this product
  • Inactive ingredients

    aloe vera, fragrance, purified water, triethanolamine

  • Principal Display Panel - Pouch Label

    HENRY SCHEIN®

    NDC 0404-0122-01

    REF 570-1490

    ANTIMICROBIAL
    HAND WIPES

    HERNY SCHEIN

    SEAL OF EXCELLENCE®

    Kills 99.9% of Germs

    Contains 66.5% Ethyl Alcohol

    Enriched with Aloe Vera

    Contains: 1 single-use, Premoistened Towelette

    2 Do not reuse

    Distributed by:

    HENRY SCHEIN INC. Melville, NY 11747 USA

    Made in U.S.A. Rev. 10/19

    Principal Display Panel - Pouch Label
  • Principal Display Panel - Box Label

    HENRY SCHEIN®

    NDC 0404-0122-02

    REF 570-1490

    ANTIMICROBIAL
    HAND WIPES

    HERNY SCHEIN

    SEAL OF EXCELLENCE®

    Kills 99.9% of Germs

    Contains 66.5% Ethyl Alcohol

    Enriched with Aloe Vera

    100 WIPES

    Premoistened Toweletts - 5" x 8"

    2 Do not reuse

    Principal Display Panel - Box Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0122-02100 in 1 BOX11/11/2019
    1NDC:0404-0122-010.0019 L in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/11/2019
    Labeler - Henry Schein Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
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