Label: WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP- 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 January 4, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3 PERCENT

  • PURPOSE

    ANTIBACTERIAL

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN.

  • 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

    APPLY TO WET HANDS, LATHER AND RINSE THOROUGHLY.

  • QUESTIONS OR COMMENTS

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, AMMONIUM LAURYL SULFATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, GLYCOL DISTEARATE, GLYCERIN, SODIUM CHLORIDE, GLYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LACTATE, GLYCERYL STEARATE, LAVENDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, TOCOPHERYL ACETATE, BENZOPHENONE-4, DISODIUM EDTA, SODIUM HYDROXIDE, CITRIC ACID, BENZYL ALCOHOL, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), EXT. VIOLET 2 (CI 60730), RED 33 (CI 17200), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF WHITE LAVENDER AND MINT ANTIBACTERIAL HAND SP

  • INGREDIENTS AND APPEARANCE
    WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-292
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-292-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/30/2010
    Labeler - H E B (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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