Label: BREATHE IN BREATHE BERRY- ethyl 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 July 12, 2021

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  • Active Ingredients

    Ethyl Alcohol 70% v/v.................Antiseptic

  • Purpose

    Antiseptic

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Safety Instructions

    Flammable, Keep away from fire and flame

  • When using this product

    In case of contact,rinse eyes thoroughly with water

  • Do not use

    Do  not use in or near eyes.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • apply palmful to hands.
    • rub hands together vigorously until dry.
    • supervise children in the use of this product.
  • Other Information

    Store below 110°F (43°C)
    May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Yellow 5, Red 33

  • PRINCIPAL DISPLAY PANEL

    5

  • INGREDIENTS AND APPEARANCE
    BREATHE IN BREATHE   BERRY
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-032-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/14/2020
    Labeler - Flex Beauty Labs (080858917)
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