SECURA MOISTURIZING 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 Moisturizing 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 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)

REF 59430800

NDC 69740-308-00

Moisturizing
Cleanser

Antimicrobial Skin Cleanser

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

Smith&Nephew
Secura◊
Moisturizing Cleanser

4 fl. oz. (118 mL)

Made in the 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 Patent Office and Tm. Off.

Package Display - Bottle, Spray (118mL)

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

REF 59430900

NDC 69740-309-00

Moisturizing
Cleanser

Antimicrobial Skin Cleanser

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

Smith&Nephew
Secura◊
Moisturizing Cleanser

8 fl. oz. (236 mL)

Made in the 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 Patent Office and Tm. Off.

Package Display - Bottle, Spray (236mL)

SECURA MOISTURIZING CLEANSER
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-309
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)	2 uL in 1 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.001 uL in 1 mL
ALOE (UNII: V5VD430YW9)	0.05 uL in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	10 uL in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	30 uL in 1 mL
WATER (UNII: 059QF0KO0R)	945.94 uL in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.2 uL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-309-00	236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003

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

SECURA MOISTURIZING CLEANSER
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-308
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)	0.05 uL in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	2 uL in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.2 uL in 1 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.001 uL in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	10 uL in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	30 uL in 1 mL
WATER (UNII: 059QF0KO0R)	945.94 uL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-308-00	118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003

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

Labeler - Smith & Nephew Medical Ltd (216344051)

Name	Address	ID/FEI	Business Operations
Establishment
Swiss American CDMO LLC		080170933	MANUFACTURE(69740-309, 69740-308)

Revised: 8/2017

Document Id: 741d5f32-12ec-4170-8ac4-34159856590b

Set id: 337e4ea5-5c41-41dc-811c-e44d38269847

Version: 2

Effective Time: 20170823

Smith & Nephew Medical Ltd