Label: GREEN F5 SANITIZING HAND WIPES- alcohol cloth

  • 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 March 27, 2021

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antimicrobial

  • Use

    • Sanitizing wipes to help reduce bacterial on the skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

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

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    • Tear Open, unfold and apply to hands
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Tromethamine, Carbomer, Glycerin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Sophora Flavescens Extract, Aloe Barbadensis Extract, Perfume

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    GREEN F5 SANITIZING HAND WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81711-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81711-001-015000 g in 1 POUCH; Type 0: Not a Combination Product03/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/27/2021
    Labeler - SUPERMAN.CO.,LTD (689846771)
    Registrant - SUPERMAN.CO.,LTD (689846771)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMACOS KOREA695625857manufacture(81711-001)
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