Label: GREEN PUMP- alcohol gel

  • 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 February 5, 2021

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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Use

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

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes, ears, and mouth. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs, those may be signs of a seerious condition.

    Keep out of reach of children.

  • Other information

    • Store betweem 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (140°F)
  • 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

  • Inactive ingredients

    Water, Glycerin, D-Panthenol, Carbomer, Polyoxyethylene hydrogenated caster oil, Orange Yu, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    GREEN PUMP 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81532-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PEG-10 HYDROGENATED CASTOR OIL (UNII: MH590ECD4O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81532-001-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/05/2021
    Labeler - JM World Co., Ltd. (688319123)
    Registrant - JM World Co., Ltd. (688319123)
    Establishment
    NameAddressID/FEIBusiness Operations
    JM World Co., Ltd.688319123manufacture(81532-001)
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