SECURA MOISTURIZING CLEANSER- benzethonium chloride spray

Secura Moisturizing Cleanser by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Benzethonium chloride 0.13%

PURPOSE

Antimicrobial

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

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 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.

INGREDIENTS AND APPEARANCE

SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50484-309
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 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50484-309-00	236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2003	12/31/2022

SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50484-308
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 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50484-308-00	118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2003	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2003	12/31/2022

Labeler - Smith & Nephew, Inc. (827731451)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(50484-309, 50484-308)