Label: AROMA GUARDIAN- anti bacterial instant hand sanitizer gel

  • NDC Code(s): 42477-2012-1
  • Packager: Opal Cosmetics (Huizhou) Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated April 6, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Flammable. For external use only. Keep away from heat or flame.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Do not store above 105℉ (40.6℃)
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • Inactive ingredients

    Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, t-Butyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Maltodextrin, Denatonium Benzoate.

  • Package Label - Principal Display Panel

    95

  • INGREDIENTS AND APPEARANCE
    AROMA GUARDIAN 
    anti bacterial instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42477-2012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.075 mL  in 95 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.38 mL  in 95 mL
    WATER (UNII: 059QF0KO0R) 27.36 mL  in 95 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.9 mL  in 95 mL
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.285 mL  in 95 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42477-2012-195 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2020
    Labeler - Opal Cosmetics (Huizhou) Limited (528178475)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Opal Cosmetics (Huizhou) Limited528178475label(42477-2012) , manufacture(42477-2012)
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