Label: INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 61010-1112-0, 61010-1112-5, 61010-1112-6
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol 66.5%

  • 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 usein the eyes. If this happens, rinse thoroughly with water

    Stop use and ask doctor ifirritation and redness develop and persists for more than 72 hours

    Keep out of reach of childrenIf ingested get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands & wrists 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

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215 800-456-7077
    www.safetec.com

  • PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label

    Safetec

    instant

    Hand

    Sanitizer

    Kills 99.9% of Germs

    Enriched with

    Aloe Vera

    Fresh

    8.0 FL. OZ. (237 ML)

    PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1112
    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)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-1112-50.118 L in 1 BOTTLE; Type 0: Not a Combination Product03/22/2012
    2NDC:61010-1112-60.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/22/2012
    3NDC:61010-1112-00.046 L in 1 BOTTLE; Type 0: Not a Combination Product03/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/22/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-1112)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!