Label: INSTANT 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, 2010

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  • SPL UNCLASSIFIED SECTION

    Safetec of America, Inc.

    Instant Hand Sanitizer

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin without soap and water
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from fire or flame

  • DO NOT USE

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

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

  • Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

    Supplied by

    STATINA

    HEALTHCARE AUSTRALIA

    3/12 Yatala Rd.

    Mt. Kuring-Gai, NSW, 2080

    1300 365 404

    www.statina.com.au

  • PRINCIPAL DISPLAY PANEL

    NDC 61010-4111-0

    Safetec

    instant

    Hand

    Sanitizer

    Kills 99.9% of Germs

    Enriched with

    Aloe Vera

    Fresh

    16 FL. OZ. (473 ML)

    Reorder No. 17358

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol0.7 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4111-0473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/15/2010
    Labeler - Safetec of America (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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