Label: ACCURATE LABS ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid

  • NDC Code(s): 78434-110-02, 78434-110-04, 78434-110-08, 78434-110-16, view more
    78434-110-32, 78434-110-64, 78434-110-70, 78434-110-75, 78434-110-80, 78434-110-85, 78434-110-90
  • Packager: Accurate Labs, LLC
  • 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 October 7, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 80% v/v

  • 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 20-25°C (68-77°F)
    • avoid freezing and excessive heat above 40°C (104°F)
    • may discolor certain fabrics

  • Inactive ingredients

    d-limonene, glycerin, water

  • Questions?

    1-800-484-1699

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

  • SPL UNCLASSIFIED SECTION

    Alcohol Antiseptic 80%

    Topical Solution

    Non-Sterile Solution

    Manufactured for: Accurate Labs, LLC
    301W 50th St, Odessa, TX 79764

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ACCURATE LABS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78434-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78434-110-020.059 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
    2NDC:78434-110-040.118 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
    3NDC:78434-110-080.236 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
    4NDC:78434-110-160.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
    5NDC:78434-110-320.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
    6NDC:78434-110-641.89 L in 1 BOTTLE; Type 0: Not a Combination Product06/01/202006/30/2025
    7NDC:78434-110-703.79 L in 1 BOTTLE; Type 0: Not a Combination Product06/01/202006/30/2025
    8NDC:78434-110-759.46 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
    9NDC:78434-110-8018.93 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
    10NDC:78434-110-85208.2 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
    11NDC:78434-110-901211.3 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/202006/30/2025
    Labeler - Accurate Labs, LLC (113427259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accurate Labs, LLC113427259manufacture(78434-110)
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