Label: AROMA GUARDIAN- anti bacterial instant hand sanitizer gel

  • NDC Code(s): 42477-2022-1
  • Packager: Opal Cosmetics (Huizhou) Limited
  • 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 April 17, 2020

If you are a consumer or patient please visit this version.

  • 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:42477-2022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71.25 mL  in 95 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.475 mL  in 95 mL
    WATER (UNII: 059QF0KO0R) 21.47 mL  in 95 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.52 mL  in 95 mL
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.285 mL  in 95 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42477-2022-195 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/17/2020
    Labeler - Opal Cosmetics (Huizhou) Limited (528178475)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Opal Cosmetics (Huizhou) Limited528178475label(42477-2022) , manufacture(42477-2022)