Label: TRANSFORMERS BRAVE BERRY HAND SANITIZER- alcohol kit

  • 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 14, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 69% v/v

  • Purpose

    Antiseptic

  • Use

    for hand-washing to decrease bacteria on the skin, only when water is not available

  • Warnings

    For external use only

    Flammable, keep away from fire and flames

    When using this product

    • do not get into eyes.
    • if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
  • Other information

    • Store at 68F to 77F (20C - 25C)
    • Do not store above 110F (43C)
    • You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536
  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Yellow 5, Red 40.

  • Company Information

    MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC

    2433 KNAPP ST. BROOKLYN, NY 11235

  • Product Packaging

    TFMR 200 jpg

  • INGREDIENTS AND APPEARANCE
    TRANSFORMERS BRAVE BERRY HAND SANITIZER 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-965
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74177-965-011 in 1 KIT; Type 0: Not a Combination Product12/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 89 mL
    Part 21 BOTTLE, PLASTIC 89 mL
    Part 31 TUBE 3.4 g
    Part 1 of 3
    BRAVE BERRY SCENT HAND SOAP 
    other personal cleanliness products soap
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 2 of 3
    BRAVE BERRY SCENT HAND SANITIZER 
    alcohol gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/11/2020
    Part 3 of 3
    TOUGH CITRUS LIP BALM 
    lipstick lipstick
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRCERESIN (UNII: Q1LS2UJO3A)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/11/2020
    Labeler - K7 Design Group Inc. (080357784)
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