SECURA PERSONAL CLEANSER- benzethonium chloride spray 
Smith & Nephew Medical Ltd

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.

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Secura Personal Cleanser

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, feces, or other foreign material

WARNINGS

  • For external use only
  • Avoid contact with eyes

  • Not to be applied over deep 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, octoxynol-9, sodium citrate, polysorbate 20, propylene glycol, citric acid, diazolidinyl urea, polyquaternium-4, benzyl alcohol, methylparaben, fragrance, disodium EDTA, D&C Red #33

QUESTION OR COMMENTS?

1 800 876-1261

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

#59430400

NDC 69740-304-00

Personal Cleanser

Antimicrobial Skin Cleanser

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

Smith&Nephew
Secura◊
Personal Cleanser

8 fl oz. (236mL)

Made in 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 U.S. Pat. And Tm. Off

Package Display - Personal Cleanser (236 mL)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL CLEANSER (3.78L)

#59430500
NDC 69740-305-00

Personal Cleanser

Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces odor
  • pH-buffered
  • Pediatrician tested
  • CHG Compatible

Smith&Nephew
Secura◊
Personal Cleanser

1 Gallon (3.78L)

Made in USA for:

Smith & Nephew Medical LTD
101 Hessle Road
Hull, HU3 2BN
England
www.smith-nephew.com
Trademark of Smith & Nephew.

Package Display - Personal Cleanser (236 mL)

SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69740-304-00236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/200311/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200311/30/2023
SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69740-305-003780 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/200311/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200311/30/2023
Labeler - Smith & Nephew Medical Ltd (216344051)
Establishment
NameAddressID/FEIBusiness Operations
Swiss American CDMO LLC080170933MANUFACTURE(69740-304, 69740-305)

Revised: 2/2021
Document Id: 9a03e121-086c-4596-8730-39747f546fc9
Set id: bc49dd17-f589-4013-a2aa-782166f6da1d
Version: 3
Effective Time: 20210210
 
Smith & Nephew Medical Ltd