Label: BALANSE NYC HAND SANITIZER- ethyl alcohol liquid

  • 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 2, 2020

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  • Active lngredient  

    Ethyl Alcohol 70%

  • Purpose 

    Antiseptic 

  • Uses 

    Hand sanitizer to help decrease bacteria on the skin. When water, soap and towel are not available. Recommended for repeated use

  • Warnings:

    For external use only.
    Flammable. Keep away from fire or flame
    Do not apply around eyes. Do not use in ears & mouth
    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

  • Keep out of reach of children.

    Children must be supervised in use of this product

  • Directions

    • Place enough product in your palm to spread on both hands.
    • Rub your hands together thoroughly until dry.
    • Children under 6 years of age should be supervised by an adult when using this product to avoid swallowing.
  • Inactive ingredients

    Aqua, Glycerine, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    BALANSE NYC HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74094-001
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74094-001-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - YASHVIRE LLC (117396744)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARSHALLS TRADITIONAL HEALTHCARE CC637662219manufacture(74094-001)
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