Label: EQUALINE LIQUID- 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 April 4, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES.  IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOP.

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    SQUEEZE ONTO WET HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, DECYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, SODIUM CHLORIDE, PEG-18 GLYCERYL OLEATE/COCOATE, FRAGRANCE , COCAMIDE MEA, DMDM HYDANTOIN, TETRASODIUM EDTA, CITRIC ACID,YELLOW 5 (CI 19140), RED 4 (CI 14700).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF PERS1

  • INGREDIENTS AND APPEARANCE
    EQUALINE  LIQUID
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-220-08222 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/04/2011
    Labeler - SUPERVALU INC (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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