Label: SIGNATURE CARE ANTIBACTERIAL FOAMING MOISTURIZING- 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 February 12, 2016

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  • Active ingredient

    Triclosan 0.46%

    Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

    Stop using this product and ask a doctor if

    irritaiton or redness develops

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Pump onto dry hands.
    • Lather vigorously for at least 15 seconds.
    • Rinse and dry thoroughly.
  • Other information

    store at room temperature

  • Inactive ingredients

    Water (Aqua), Sodium Xylenesulfonate, Dipropylene Glycol, Glycerin, Ammonium Lauryl Sulfate, Sodium PCA, Cocamidopropyl Betaine, Polyquaternium-10, Fragrance (Parfum), Disodium Phosphate, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Citric Acid, Methylparaben, Propylparaben, Red 4 (CI 14700), Yellow 5 (CI 19140).

  • Questions or comments?

    1-888-723-3929

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ANTIBACTERIAL FOAMING MOISTURIZING 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN4.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-177-07222 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 finalpart333E02/11/2016
    Labeler - SAFEWAY INC (009137209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(21130-177)
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