Label: 5406 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 December 13, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient: Ethyl alcohol 62%.

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin. 

  • WARNINGS

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

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

  • INACTIVE INGREDIENT

    Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

  • QUESTIONS

    Questions? HOTLINE # 1-855-755 5346 NPN# 80062390

  • STORAGE AND HANDLING

    Store at room temperature 15° to 30°C (59° to 86°F).

  • SPL UNCLASSIFIED SECTION

    Made in China For Innovation Line Los Angeles,
    CA 90066 Product # 5406

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    5406 HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-116(NDC:70412-110)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-116-0330 mL in 1 CONTAINER; Type 0: Not a Combination Product07/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2018
    Labeler - Innovation Specialties (030837314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Specialties030837314relabel(76138-116) , repack(76138-116)
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