Label: 62% GEL 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 August 17, 2020

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  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To help reduce bacteria on skin.

  • Warnings

    For external use only. Flammable, keep away from source of heat & fire.

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use & ask doctor if irritation occurs or redness develops & persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

  • Directions

    Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children
    under 5 should be supervised using this product.

  • Inactive ingredients

    Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • Package Label - Principal Display Panel

    SGX 62% Gel 1L1L NDC: 78044-400-05

  • INGREDIENTS AND APPEARANCE
    62% GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78044-400
    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
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SQUALANE (UNII: GW89575KF9)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78044-400-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/17/2020
    Labeler - CBIO Brand Distribution International Inc. (117495482)
    Registrant - CBIO Brand Distribution International Inc. (117495482)
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