Label: FRESHORIZE HAND SANITIZER MOISTURIZING WITH VITAMIN E- 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 April 10, 2020

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  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Ethyl Alcohol                70%      ...        Antimicrobial

  • PURPOSE

    • for Handwashing to help decrease bacteria on the skin.
    • recommended for repeated use.
  • KEEP OUT OF REACH OF CHILDREN

    Children must be supervised in use of this product.

  • INDICATIONS & USAGE

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children under 6 years in the use of this product
  • WARNINGS

    For external use only.
    Flammable. Keep away from fire or flame.

    Do not use in ears and mouth. In case of contact, flush eyes thoroughly with water.

    Stop using and ask a doctor, if  irritation and redness develop and persist for more than 72 hours.

    OTHER INFORMATION: store at 20-25 Celsius Degree (68 - 77 Fahrenheit), may discolor fabrics.

  • DOSAGE & ADMINISTRATION

    wet hands thoroughly with product, briskly rub with hands together until dry, supervise children under 6 years in the use of this product.

  • INACTIVE INGREDIENT

    Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    FRESHORIZE HAND SANITIZER MOISTURIZING WITH VITAMIN E 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74149-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74149-001-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
    2NDC:74149-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
    3NDC:74149-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    4NDC:74149-001-04296 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Registrant - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Yangjie Daily Chemicals Co.,Ltd.529648827manufacture(74149-001)