ZESTY LEMON (ETHYL ALCOHOL) GEL [SHANGHAI WEIERYA DAILY CHEMICALS FACTORY]

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ZESTY LEMON (ETHYL ALCOHOL) GEL [SHANGHAI WEIERYA DAILY CHEMICALS FACTORY]
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NDC 58194-019-01
Set ID aeb835be-5c1f-4fcd-8046-021bfbd859cb
Category HUMAN OTC DRUG LABEL
Packager Shanghai Weierya Daily Chemicals Factory
Generic Name
Product Class
Product Number
Application Number PART333A
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, PEG-12

    dimethicone, tocopheryl

    acetate, triethanomaline,

    blue 1, water

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol, 65 % v/v

  • PURPOSE

    Purpose  Antimicrobial

  • INDICATIONS & USAGE

    Uses

    hand sanitizer to help

    reduce bacteria on skin

  • DO NOT USE

    Do not use in or near the eyes.

    In case of contact, rinse eyes

    thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if

    irritation, excessive redness

    or rash develops.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Put a dime sized drop onto hands

    and rub together briskly until dry.

  • STORAGE AND HANDLING

    Other information

    Store below 110 F (43 C)

  • WARNINGS

    Warning

    For external use only


    Flammable, keep away from fire or flame.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ZESTY LEMON  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (zesty lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-019-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2014
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-019)
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