Label: MODESA ANTIBACTERIAL HAND SANITIZER LEMON- 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 December 16, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                         Purpose

    Alcohol                62%      ...        Antimicrobial

  • PURPOSE

    to help reduce bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    Children should only use this product under adult supervison. In case of accidental ingstion, seek proessional assistance or contact a Poson Control Center immediately.

  • INDICATIONS & USAGE

    Avoid contact with eyes. If contact occurs, rinse with water.

  • WARNINGS

    For external use only.
    Flammable. Keep away from hear or flame.
    Stop using and ask a doctor, if irritation and redness develops and persists for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly and rub together until dry. Recommended for repeated use.

  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance

  • PRINCIPAL DISPLAY PANEL


    image of bottle label
  • INGREDIENTS AND APPEARANCE
    MODESA ANTIBACTERIAL HAND SANITIZER LEMON 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-139-01177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/16/2014
    Labeler - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(40104-139)
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