Label: CARE ONE ANTIBACTERIAL FOAMING HAND SOAP- 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 July 17, 2009

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.46% ( PURPOSE: ANTIBACTERIAL)

  • USES

    HELPS TO REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATLEY.

  • WHEN USING THIS PRODUCT

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

  • STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IF IRRITATION OR RASH DEVELOPS AND LASTS.

  • Package Front and Back Labels

    MM01: Package Labels (Labels.jpg)Package Labels


  • INGREDIENTS AND APPEARANCE
    CARE ONE ANTIBACTERIAL FOAMING HAND SOAP   GREEN TEA
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.4600 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 74.8937 mL  in 100 mL
    BENZENESULFONIC ACID (UNII: 685928Z18A) 10.0000 mL  in 100 mL
    DIPROPYLENE GLYCOL (UNII: E107L85C40) 5.0000 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 5.0000 mL  in 100 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 1.0000 mL  in 100 mL
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 1.0000 mL  in 100 mL
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) 1.0000 mL  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.0000 mL  in 100 mL
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.0500 mL  in 100 mL
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.2000 mL  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.0500 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0010 mL  in 100 mL
    CITRIC ACID (UNII: 2968PHW8QP) 0.04500 mL  in 100 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.2000 mL  in 100 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1000 mL  in 100 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mL  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 mL  in 100 mL
    FD&C RED NO. 4 (UNII: X3W0AM1JLX) 0.0001 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-165-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/17/2009
    Labeler - Apollo Health and Beauty Care (201901209)