Label: AROMA HAND SANITIZER- hand sanitizer liquid

  • 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 January 14, 2021

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  • ACTIVE INGREDIENT

    Alcohol 75%

  • PURPOSE

    Antiseptic

  • Use(s)

    Fragrance hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

  • WARNINGS

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

  • DO NOT USE

    ln children less than 2 months of age.

    On open skin wounds.

  • WHEN USING

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

    - Spray 2-3 times in your palm to thoroughly cover your hands.Rub hands together briskly until dry.
    - Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    - Store between 15-30°C(59-86°F).
    - Avoid freezing and excessive heat above 40°C(104°F).

  • INACTIVE INGREDIENT

    Fragrance, Glycerol, Hydrogen peroxide, Water.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AROMA HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55036-001
    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)  
    P-ANISALDEHYDE (UNII: 9PA5V6656V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55036-001-0145 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/15/2021
    Labeler - Guangzhou Socci Trading Company Limited (550365940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Socci Trading Company Limited550365940manufacture(55036-001)
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