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Secura Personal Cleanser by Smith & Nephew, Inc.

Dosage form: spray
Ingredients: BENZETHONIUM CHLORIDE 1.3ug in 1mL
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-304

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.

Secura Personal Cleanser

DRUG FACTS

ACTIVE INGREDIENTS

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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

DIRECTIONS
  • spray/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 50484-304-00

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

Smith&Nephew
Secura
Personal Cleanser

8 fl oz. (236mL)


Made for:
Smith & Nephew, Inc.
St. Petersburg, FL 33716
www.smith-nephew.com
Trademark of Smith & Nephew.
Reg. U.S. Pat. & Tm. Off.



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

#59430400
NDC 50484-304-00

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

Smith&Nephew
Secura
Personal Cleanser

8 fl oz. (236mL)

Made for:
Smith & Nephew, Inc.
St. Petersburg, FL 33716
www.smith-nephew.com
Trademark of Smith & Nephew.
Reg. U.S. Pat. & Tm. Off.

SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
METHYLPARABEN 
OCTOXYNOL 9 
POLYSORBATE 20 
PROPYLENE GLYCOL 
WATER 
TRISODIUM CITRATE DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:50484-304-00236 mL in 1.0 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200307/31/2018
SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1.3 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
METHYLPARABEN 
OCTOXYNOL 9 
POLYSORBATE 20 
PROPYLENE GLYCOL 
TRISODIUM CITRATE DIHYDRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:50484-305-003.78 L in 1.0 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200307/31/2018
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIOperations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-304), manufacture(50484-305)

Revised: 07/2016
 
Smith & Nephew, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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