Label: BEAUTY FORMATION HAND SANITIZER INDIVIDUAL- 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 16, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 68% v/v

    Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Non-medical, for external use only.

    Flammable. Keep away from the fire or flame.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Centre right away.

  • Inactive Ingredients

    Aqua, Glycerol, Carbomer, Triethanolamine.

  • Direction

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BEAUTY FORMATION HAND SANITIZER INDIVIDUAL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50435-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50435-104-0110 in 1 PACKAGE08/17/2020
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/17/2020
    Labeler - Filo America (943873703)
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