Label: ANTISEPTIC- alcohol liquid

  • 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 March 20, 2012

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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 doctor if

    • irritation or redness develop and persist 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, 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 – Antimicrobial Skin Wipe packet

    Stop the spread of infection now!

    MEDISTAPH

    Antimicrobial Skin Wipe

    KILLS 99.99% OF GERMS

    One Premoistened Towelette
    For Professional Use

    Manufactured For:
    Telestar Consulting Inc. Sylmar, CA. 91342
    877-827-4488 www.medistaph.com

    PRINCIPAL DISPLAY PANEL – Antimicrobial Skin Wipe packet
  • PRINCIPAL DISPLAY PANEL – Antimicrobial Skin Wipe box

    Stop the spread of infection now!

    MEDISTAPH

    Antimicrobial Skin Wipe

    Kills 99.99% of Germs
    Effective Against MRSA
    Enriched with Aloe Vera

    100 Premoistened Towelette – 5”x8”
    For Professional Use

    PRINCIPAL DISPLAY PANEL – Antimicrobial Skin Wipe box
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51718-3111
    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 vera leaf (UNII: ZY81Z83H0X)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51718-3111-0100 in 1 BOX
    10.0019 L in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    Labeler - Telestar Consulting (963337303)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(51718-3111)
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