Label: MY LITTLE PONY ANTIBACTERIAL HAND SANITIZER WITH MOISTURIZERS- 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 February 5, 2015

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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses • hand sanitizer to help reduce bacteria on the skin, when water, soap and towel are not available. • recommended for repeated use.

  • WARNINGS

    Warnings • Flammable • Keep away from fire or flame • For external use only

  • WHEN USING

    When using this product • avoid contact with eyes • in case of eye contact flush eyes with water. • stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • SPL UNCLASSIFIED SECTION

    Other Information • store at 20°C(68-77°F). • May discolor fabrics.

  • DOSAGE & ADMINISTRATION

    Directions •Pump as needed into your palm to thoroughly spread on both hands. •rub into the skin until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients caprylyl glycol, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, tocopheryl acetate, triethanolamine, water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MY LITTLE PONY ANTIBACTERIAL HAND SANITIZER WITH MOISTURIZERS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-204
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-204-022 in 1 PACKAGE
    1NDC:40104-204-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/05/2015
    Labeler - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(40104-204)
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