Label: CANDYLAND HAND SANITIZER CL 200- 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 16, 2020

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  • Active ingredient

    Alcohol Denat. 62%

  • Purpose

    Antiseptic

  • Use

    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 fire and flames.

    When using this product

    • do not get into eyes.
    • if contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation and redness develop

    Keep out of reach of children

    If swallowed, get medical help or contact a Posion Control Center right away.

  • Directions

    • wet hands thoroughly with product and allow to dry with wiping
  • Other information

    • Store at 68 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 Acrylate Crosspolymer,

    Fragrance,

    Polysorbate 20,

    Sodium Hydroxide,

    Red 40

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    CANDYLAND HAND SANITIZER  CL 200
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-019
    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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51522-019-011 in 1 POUCH07/16/2020
    189 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 finalpart333A07/16/2020
    Labeler - Gold Orient International Limited (679905914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914manufacture(51522-019)
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