Label: SKINTEGRITY ANTIBACTERIAL HAND BLUE- triclosan soap

  • 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 13, 2011

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  • Active ingredient

    Triclosan 0.5%

  • Purpose

    Antiseptic Handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. In case of eye contact, immediately flush with water.

    Stop use and ask a doctor if

    • irritation or redness develop
    • condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • pump into wet hands
    • lather vigorously for at least 15 seconds
    • rinse and dry thoroughly
  • Inactive ingredients

    Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Blue 1.

  • Package/Label Principal Display Panel

    Skintegrity Antibacterial Hand Soap bag label

    Skintegrity Antibacterial Hand Soap bag label

    NDC 53329-043-20

    skintegrity

    antibacterial hand soap

    27 fl oz (800 mL)

  • Package Box Label - Back and Side

    Skintegrity Antibacterial Hand Soap box, back and side

    Skintegrity Antibacterial Hand Soap box, back and side

  • Package Box Label - Front and side

    Skintegrity Antibacterial Hand Soap box, front and side

    Skintegrity Antibacterial Hand Soap box, front and side

  • INGREDIENTS AND APPEARANCE
    SKINTEGRITY ANTIBACTERIAL HAND  BLUE
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LEUCINE (UNII: GMW67QNF9C)  
    SERINE (UNII: 452VLY9402)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    ARGININE (UNII: 94ZLA3W45F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-043-201 in 1 BOX
    1800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2011
    Labeler - Medline Industries, Inc. (025460908)
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