Label: RITE AID FOAMING HAND- 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 October 7, 2010

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  • Active Ingredient

    Triclosan 0.6%

  • Purpose

    Antibacterial

  • Warnings

    For external use only.

    When using this product

    - Avoid contact with eyes. If contact occurs, rinse with water.

    Stop using this product and ask doctor if

    - irritation or redness develops and lasts.

    Keep out of reach of children.

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

  • Directions

    • Use only to refill a foaming hand soap pump bottle.
    • Pump onto dry hands, work vigorously into a lather and rinse thoroughly.
  • Uses

    For washing to decrease bacteria on the skin

  • Inactive Ingredients

    Water (Aqua), Sodium Xylenesulfonate, Dipropylene Glycol, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Fragrance(Parfum), Disodium Phosphate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone,Yellow 5 (CI 19140), Red 40 (CI 16035).

  • Package Front and Back Labels

    ra32.jpg32 OZ Front and Back Labels

  • INGREDIENTS AND APPEARANCE
    RITE AID  FOAMING HAND
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1683-2946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/07/2010
    Labeler - RITE AID CORPORATION (014578892)
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