SECURA PERSONAL CLEANSER- benzethonium chloride spray

Secura Personal Cleanser by

Drug Labeling and Warnings

Secura Personal Cleanser by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd, Swiss American CDMO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

INGREDIENTS AND APPEARANCE

SECURA PERSONAL CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-304-00	236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2003

SECURA PERSONAL CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-305-00	3780 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO LLC		080170933	MANUFACTURE(69740-304, 69740-305)