VYTIS SHIELD ALOE VERA FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [VYTIS SHIELD, LLC]

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VYTIS SHIELD ALOE VERA FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [VYTIS SHIELD, LLC]
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NDC 70299-001-00, 70299-001-01, 70299-001-02
Set ID 7981633d-afc5-4bc1-9c2b-76c1a7b4c486
Category HUMAN OTC DRUG LABEL
Packager Vytis Shield, Llc
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic Hand Sanitizer

  • Uses

    Hand Sanitizer to help decrease bacteria on the skin.

    • Recommended for repeated use.
  • Warnings

    For external use only.

    Do not use

    in ears or mouth.

    When using this product

    avoid contact with the eyes.

    • In case of contact flush eyes with water.

    Stop use and ask a doctor

    if redness or irritation develops and persists for more than 72 hours.

    Keep out of reach of children.

    Children should be supervised when using this product. Do not freeze.

  • Directions

    Apply a small amount into palms of hands and spread on both hands. Rub into skin until dry.

  • Inactive Ingredients

    1-Octadecanaminium NN dimethyl (3-trimethoxysilyl) propyl chloride, Aloe Barbadenis leaf extract, C12-C15 Pareth 12, Caprylyl Glucoside, Citric Acid Monohydrate, Citronellol, FD&C Blue 1, Glycerin, Polyaminopropyl biguanide, Sodium benzoate, Water

  • Questions or comments

    Call:1-888-489-2719

    Mon. - Fri. 9:00 AM to 5:00 PM (EST)

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    VYTIS SHIELD ALOE VERA FOAM HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70299-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70299-001-001 in 1 BOX12/03/2015
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70299-001-011 in 1 BOX12/03/2015
    2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70299-001-021 in 1 BOX12/03/2015
    31000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/03/2015
    Labeler - Vytis Shield, Llc (039382748)
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