Label: ARTEC MED ANTIBACTERIAL HAND SANITIZER- alcohol solution

  • 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 May 15, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    Flammable. Keep away from fire and flame

    For external use only.

  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact, flush eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Apply suitable amount of product in your palm and spread thoroughly on both hands. Rub onto skin until dry

  • Other information

    Store below 105F

  • Inactive ingredients

    Water, Glycerin, Parfum, Aloe Barbadensis Leaf Juice, Hydrogen Peroxide, Triethanolamine, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ARTEC MED ANTIBACTERIAL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76352-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76352-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:76352-101-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:76352-101-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:76352-101-04180 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    5NDC:76352-101-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    6NDC:76352-101-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    7NDC:76352-101-07600 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - Artec Chemical Company Limited (421271074)
    Establishment
    NameAddressID/FEIBusiness Operations
    Artec Chemical Company Limited421271074manufacture(76352-101)
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