SECURA TOTAL BODY FOAM CLEANSER- benzethonium chloride spray

Secura Total Body Foam Cleanser by

Drug Labeling and Warnings

Secura Total Body Foam Cleanser by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd., Swiss-America CDMO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 liberally on affected area, then wipe clean
• no rinsing necessary

OTHER INFORMATION

Keep bottle upright, do not shake. Remove cap, depress nozzle.

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- BOTTLE, PUMP (133mL)

REF #59430200

NDC 69704-302-00
Total Body
Foam Cleanser

Antimicrobial Skin Cleanser

• High-density foam for body and hair
• No-rinse, one-step cleansing
• Gently removes urine, feces, and other foreign material
• Reduces odor
• pH-buffered
• Pediatric tested
• CHG compatible

Smith & Nephew

Secura◊

Total Body

Foam Cleanser

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 US Pat. & Tm Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PABEL- BOTTLE, PUMP (250mL)

REF #59430300

NDC 69740-303-00

Total Body 
Foam Cleanser

Antimicrobial Skin Cleanser

• High-density foam for body and hair
• No-rinse, one-step cleansing
• Gently removes urine, feces, and other foreign material
• Reduces odor
• pH-buffered
• Pediatric tested
• CHG compatible

Smith & Nephew

Secura◊

Total Body

Foam Cleanser

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 US Pat. & Tm Off.

INGREDIENTS AND APPEARANCE

SECURA TOTAL BODY FOAM CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	.013   in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	2 uL  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	3.08 uL  in 1 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	3 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.1 uL  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	1 uL  in 1 mL
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)	20 uL  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	10 uL  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10 uL  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	17.13 uL  in 1 mL
WATER (UNII: 059QF0KO0R)	929.389 uL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-303-00	250 mL in 1.0 BOTTLE, PUMP; 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 TOTAL BODY FOAM CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.013   in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	2 uL  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	3.08 uL  in 1 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	3 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.1 uL  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	1 uL  in 1 mL
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)	20 uL  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	10 uL  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10 uL  in 1 mL
WATER (UNII: 059QF0KO0R)	929.389 uL  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	17.3 uL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-302-00	133 mL in 1.0 BOTTLE, PUMP; 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-America CDMO LLC		080170933	MANUFACTURE(69740-303, 69740-302)