Label: RITE AID RENEWAL ANTIBACTERIAL- triclosan liquid

  • 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 December 21, 2012

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

    PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR

    IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IF INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    APPLY A SMALL AMOUNT ONTO WET HANDS. WORK INTO A RICH LATHER AND RINSE CLEAN.

  • INACTIVE INGREDIENTS

    WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, LAURAMIDE DEA, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), CITRIC ACID, DMDM HYDANTOIN, GLYCERIN, TETRASODIUM EDTA, POLYQUATERNIUM-7, HYDROLYZED SILK PROTEIN, ALOE BARBADENSIS LEAF JUICE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    RITE AID RENEWAL  ANTIBACTERIAL
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2160-8221 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2012
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(11822-2160)
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