Label: MY LITTLE PONY(MLP 103)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 July 20, 2020

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  • Active Ingredient(s)

    Alcohol 62% v/v.

  • Purpose

    Antiseptic

  • Use

    For hand-washing to decrease bacteria on the skin, only when water is not available

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    Do not get into eyes.

    if contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Irritation and redness develop

  • 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
  • Other information

    • Store between 66 to 77F (20-25C)
    • Do not store above 110F (43C)
    • You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22 Plainsboro, NJ 08536
  • Inactive ingredients

    Water, Glycerin, Acrylates/ C10-30 Alkyl Acrylates Crosspolymer, Fragrance, Polysorbate 20, Sodium Hydroxide, Red 33, Blue 1

  • Package Label - Principal Display Panel

    Label Artwork

  • INGREDIENTS AND APPEARANCE
    MY LITTLE PONY(MLP 103)HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-029
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51522-029-011 in 1 POUCH03/30/2020
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Gold Orient International Limited (679905914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914manufacture(51522-029)
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