Label: FELD APOTHEKE HAND SANITIZER- 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 April 6, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 62%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Carbomer, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice,
    Camellia Sinensis Leaf Extract, Hinokitiol, Triethanolamine, Flavor

  • PURPOSE

    Purpose:SANITIZER

  • WARNINGS

    Warnings:

    For external use only

    * Keep away from heat and flame
    * Do not use in mouth, ears or eyes.
    * When using this product, avoid contact with eyes.
    * In case of contact, flush eyes with water.
    * Stop use and seek a doctor if redness or irritation develops
    * Keep out of reach of children
    * Children should be supervised when using this product.
    * Store in a cool place.
    * keep out of direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Disinfection of hands and skin

  • Directions

    Directions:
    Take an appropriate amount on your hands and rub thoroughly to dry.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    FELD APOTHEKE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74381-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL86.8 g  in 140 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74381-010-01140 mL in 1 CONTAINER; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Iphilo (695625968)
    Registrant - Iphilo (695625968)
    Establishment
    NameAddressID/FEIBusiness Operations
    GREENWONIL CO., LTD.688442099manufacture(74381-010)
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