Label: ALPHA HANDRUB ANTISEPTIC HAND SANITIZER- ethyl 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 November 17, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75 %

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if
    • irritation and redness develop
    • condition 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
    • sealed cap

  • Inactive ingredients

    carbomer 940, glycerin, hydrogen peroxide, water

  • Questions?

    +1-877-962-2636
    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Alpha Cleantech Labs Inc., Unit 111 – 20351 Duncan Way,

    Langley, British Columbia, V3A 7N3

    COUNTRY OF ORIGIN : CANADA

    Website: www.alphacleantech.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ALPHA HANDRUB ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77959-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77959-202-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2020
    2NDC:77959-202-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2020
    3NDC:77959-202-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2020
    4NDC:77959-202-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2020
    5NDC:77959-202-2018927 mL in 1 CONTAINER; Type 0: Not a Combination Product11/17/2020
    6NDC:77959-202-55208198 mL in 1 CONTAINER; Type 0: Not a Combination Product11/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/17/2020
    Labeler - Alpha Cleantech Labs Inc (204074603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alpha Cleantech Labs Inc204074603manufacture(77959-202)
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