Label: ANTIMICROBIAL HAND SANITIZING MANGO SCENTED- ethyl alcohol lotion

  • 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 January 7, 2021

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  • Active Ingredient:

    Ethyl Alcohol 62 percent

  • DOSAGE & ADMINISTRATION

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Purpose:

    Antiseptic

  • WARNINGS

    For external use only. Flammable. Keep away from heat and flame.

  • When using this product

    • Do not use in eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
  • STOP USE

    Discontinue use if skin irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

  • 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.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Children under 6, use only under adult supervision
    • Not recommended for infants
  • Other Information

    • Do not store above 105 degrees F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Benzophenone-4, Carbomer, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Water


  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND SANITIZING MANGO SCENTED 
    ethyl alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49725-926
    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
    SULISOBENZONE (UNII: 1W6L629B4K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49725-926-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/28/2009
    Labeler - HandsFree (837204945)
    Registrant - Xiamen Royaltech Packaging Co., Ltd. (529325521)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Royaltech Packaging Co., Ltd.529325521manufacture(49725-926)