Label: BEAUTY FORMATION HAND SANITIZER- alcohol solution

  • Category: HUMAN OTC DRUG LABEL

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 September 1, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 68% 

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only.

    Non Medical. Flammable. Keep away from fire or flame

    When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together brisky until dry
  • Inactive ingredients

    Water, Glycerol, Carbomer, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BEAUTY FORMATION HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71004-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71004-104-0110 in 1 PACKAGE08/14/2020
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71004-104-0210 in 1 PACKAGE08/14/2020
    25 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/20/2020
    Labeler - iHotel Guest Amenities Co.,Ltd (421299845)
    Establishment
    NameAddressID/FEIBusiness Operations
    iHotel Guest Amenities Co.,Ltd421299845manufacture(71004-104)
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