Label: RITE AID RENEWAL- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.46%

    PURPOSE

    ANTIBACTERIAL

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  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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  • DIRECTIONS

    USE ONLY TO REFILL A FOAMING HAND SOAP PUMP BOTTLE. APPLY ONTO DRY HANDS. WORK INTO A RICH FOAMY LATHER, RINSE AND DRY THOROUGHLY.

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

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  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, SODIUM PCA, ALOE BARBADENSIS LEAF JUICE POWDER, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700), YELLOW 5 (CI 19140).

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    RITE AID RENEWAL 
    triclosan liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-1793
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 4.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    COCAMIDOPROPYL BETAINE  
    POLYETHYLENE GLYCOL 400  
    SODIUM XYLENESULFONATE  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    SODIUM PYRROLIDONE CARBOXYLATE  
    ALOE VERA LEAF  
    CITRIC ACID MONOHYDRATE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    FD&C RED NO. 4  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-1793-2 946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 04/18/2013
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(11822-1793)
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