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 19, 2015

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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
  • Warnings

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

    Do not use in the eyes. If this happens, rinse 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

    • unsnap entire canister cap and thread towelette through pre-cut slot
    • pull towelette out of cap slot at an angle to dispense
    • wet hands and wrists thoroughly with wipe for 15 seconds and allow to air dry
    • dispose of used towelette properly
    • always reseal after use
    • children under 6 years of age should be supervised when using this product
  • Inactive ingredients

    aloe vera, fragrance, purified water, triethanolamine

  • Principal Display Panel - Canister Label

    NDC 51718-3112-1

    MEDISTAPH
    COMPLETE CARE

    Pop Up Antimicrobial Wipes

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

    160 Premoistened Towlettes (5" x 8")

    Reorder no. 54808

    Principal Display Panel - Canister Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51718-3112
    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:51718-3112-10.52 L in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/19/2015
    Labeler - Telestar (963337303)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(51718-3112)
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