SECURA MOISTURIZING CLEANSER- benzethonium chloride spray 
Smith & Nephew, Inc.

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 Moisturizing 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 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)

Item #59430800
NDC 50484-308-00

Moisturizing
Cleanser


Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces odor
  • Non-irritating
  • pH-balanced
  • Contains Aloe and  Glycerin to condition, soothe, and moisturize skin
  • Pediatrician-tested

Smith&Nephew
Secura◊
Moisturizing Cleanser

4 fl. oz. (118mL)


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

Package Display - Bottle, Spray (118m)

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

Item #59430900
NDC 50484-309-00

Moisturizing
Cleanser

Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces odor
  • Non-irritating
  • pH-balanced
  • Contains Aloe and  Glycerin to condition, soothe, and moisturize skin
  • Pediatrician-tested

Smith&Nephew
Secura◊
Moisturizing 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 Display - Bottle, Spray (236mL)

SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-309
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-309-00236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/200312/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200312/31/2020
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-308
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)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-308-00118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/200312/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200312/31/2020
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-309, 50484-308)

Revised: 9/2020
Document Id: 5005e5eb-ef1a-4b70-86d4-ab2de2de0d38
Set id: 5d2b1826-8ee0-4ca6-b930-f3c515dd4619
Version: 6
Effective Time: 20200904
 
Smith & Nephew, Inc.