Label: SECURA MOISTURIZING CLEANSER- benzethonium chloride spray

  • 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 August 23, 2017

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Benzethonium chloride 0.13%

  • PURPOSE

    Antimicrobial

  • USES

    • antimicrobial skin cleanser for the perineum or body
    • aids in the removal of urine and feces, or other foreign material
  • WARNINGS

    • For external use only
    • Avoid contact with eyes

    • Not to be applied over deep or puncture wounds, infections or lacerations

    • If condition worsens or does not improve within 7 days, contact a doctor

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately 
  • DIRECTIONS

    • apply cleanser liberally on affected area, then wipe clean
    • no rinsing necessary
  • INACTIVE INGREDIENTS

    water, polysorbate 20, glycerin, polyquaternium-10, benzyl alcohol, fragrance, disodium EDTA, aloe barbadensis, FD&C Blue #1

  • QUESTION OR COMMENTS?

    1 800 876-1261

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER (118mL)

    REF 59430800

    NDC 69740-308-00

    Moisturizing
    Cleanser

    Antimicrobial Skin Cleanser

    • No-rinse, one-step cleansing for perineum or body
    • Gently removes urine, feces, and other body fluids
    • Reduces odor
    • pH-balanced
    • Pediatric-tested
    • CHG compatible

    Smith&Nephew
    Secura◊
    Moisturizing Cleanser

    4 fl. oz. (118 mL)

    Made in the USA for
    Smith & Nephew Medical Ltd,
    101 Hessle Road
    Hull, HU3 2BN, England
    www.smith-nephew.com
    ◊Trademark of Smith & Nephew.

    Certain marks reg’d in US Patent Office and Tm. Off.

    Package Display - Bottle, Spray (118mL)

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER (236mL)

    REF 59430900

    NDC 69740-309-00

    Moisturizing
    Cleanser

    Antimicrobial Skin Cleanser

    • No-rinse, one-step cleansing for perineum or body
    • Gently removes urine, feces, and other body fluids
    • Reduces odor
    • pH-balanced
    • Pediatric-tested
    • CHG compatible

    Smith&Nephew
    Secura◊
    Moisturizing Cleanser

    8 fl. oz. (236 mL)

    Made in the USA for
    Smith & Nephew Medical Ltd,
    101 Hessle Road
    Hull, HU3 2BN, England
    www.smith-nephew.com
    ◊Trademark of Smith & Nephew.

    Certain marks reg’d in US Patent Office and Tm. Off.

    Package Display - Bottle, Spray (236mL)

  • INGREDIENTS AND APPEARANCE
    SECURA MOISTURIZING CLEANSER 
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL  in 1 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 uL  in 1 mL
    ALOE (UNII: V5VD430YW9) 0.05 uL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 10 uL  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 uL  in 1 mL
    WATER (UNII: 059QF0KO0R) 945.94 uL  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 uL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-309-00236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2003
    SECURA MOISTURIZING CLEANSER 
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9) 0.05 uL  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 uL  in 1 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 uL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 10 uL  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 uL  in 1 mL
    WATER (UNII: 059QF0KO0R) 945.94 uL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-308-00118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2003
    Labeler - Smith & Nephew Medical Ltd (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss American CDMO LLC080170933MANUFACTURE(69740-309, 69740-308)
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