SWISS HAND GUARD ANTISEPTIC HANDWASH ANTIBACTERIAL (ALCOHOL) GEL [OPI PRODUCTS IN]

SWISS HAND GUARD ANTISEPTIC HANDWASH ANTIBACTERIAL (ALCOHOL) GEL [OPI PRODUCTS IN]
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NDC 61852-046-01, 61852-046-02, 61852-046-03, 61852-046-04
Set ID b574b2e3-fad2-42fa-9f8c-9a9695cf5b62
Category HUMAN OTC DRUG LABEL
Packager OPI Products In
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Alcohol 67%

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    for hand washing to decrease bacteria on the skin

    recommended for repeated use

  • WARNINGS

    For external use only

    Flammable, keep away from fire or flame

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and consult a physician if irritation and redness develop and persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    to be used without water

    place a small amount of products in the hand

    spread over both hands and rub into the skin until dry

  • INACTIVE INGREDIENT

    Water, Carbomer Sorbitol, Ethyhexyl Palmitate, Mentha Piperita (Peppermint) Oil, Menthol, Eucalyptus Globulus Leaf Oil, Tromethamine, Drometrizole, Limonene, Linalool, CI 17200 (Red 33).

  • PRINCIPAL DISPLAY PANEL

    shg 120

  • INGREDIENTS AND APPEARANCE
    SWISS HAND GUARD  ANTISEPTIC HANDWASH ANTIBACTERIAL
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61852-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80.4 mL  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Menthol (UNII: L7T10EIP3A)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Tromethamine (UNII: 023C2WHX2V)  
    Drometrizole (UNII: 5X93W9OFZL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61852-046-01120 mL in 1 BOTTLE
    2NDC:61852-046-02240 mL in 1 BOTTLE
    3NDC:61852-046-03480 mL in 1 BOTTLE
    4NDC:61852-046-04960 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A01/31/2012
    Labeler - OPI Products In (967172854)
    Registrant - Coty Inc (958662223)
    Establishment
    NameAddressID/FEIBusiness Operations
    OPI Products Inc967172854manufacture

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