Package Insert and Label Information: Secura Personal Cleanser

By Smith & Nephew, Inc. | Last revised: 31 December 2009

SECURA PERSONAL 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.

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.

(click image for full-size original)

Package Display — Personal Cleanser (236 mL)

SECURA PERSONAL CLEANSER
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50484-304
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM)	BENZETHONIUM CHLORIDE	1.3 uL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL	2 uL in 1 mL
CITRIC ACID	3.08 uL in 1 mL
D&C RED NO. 33
DIAZOLIDINYLUREA	3 uL in 1 mL
EDETATE DISODIUM	1 uL in 1 mL
METHYLPARABEN	1 uL in 1 mL
OCTOXYNOL 9	20 uL in 1 mL
POLYSORBATE 20	10 uL in 1 mL
PROPYLENE GLYCOL	10 uL in 1 mL
WATER	929.389 uL in 1 mL
TRISODIUM CITRATE DIHYDRATE	171.3 uL in 1 mL

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50484-304-00	236 mL in 1 BOTTLE, SPRAY	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/01/2003

SECURA PERSONAL CLEANSER
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50484-305
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM)	BENZETHONIUM CHLORIDE	1.3 mL in 1 L

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL	2 mL in 1 L
CITRIC ACID	3.08 mL in 1 L
D&C RED NO. 33
DIAZOLIDINYLUREA	3 mL in 1 L
EDETATE DISODIUM	0.1 mL in 1 L
METHYLPARABEN	1 mL in 1 L
OCTOXYNOL 9	20 mL in 1 L
POLYSORBATE 20	10 mL in 1 L
PROPYLENE GLYCOL	10 mL in 1 L
TRISODIUM CITRATE DIHYDRATE	171.3 mL in 1 L
WATER	929.389 mL in 1 L

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50484-305-00	3.78 L in 1 BOTTLE, SPRAY	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/01/2003

Labeler — Smith & Nephew, Inc. (827731451)

Establishment
Name	Address	ID/FEI	Operations
Swiss-America Products, Inc.		611921669	MANUFACTURE

Revised: 12/2009 Smith & Nephew, Inc.