SECURA PERSONAL SKIN CARE KIT- benzethonium chloride,petrolatum kit

Secura Personal Skin Care Kit by

Drug Labeling and Warnings

Secura Personal Skin Care Kit by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd, Swiss-America Products, Inc., ENCUBE ETHICALS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

​#59434300

​NDC: 69740-343-00

​Personal Skin Care Kit

Good skin care can help prevent breakdown

DIRECTIONS

1. Change wet and soiled diapers, garments, and linens promptly. Spray cleanser liberally on affected area.
2. Wipe clean with tissues, and remove soiled underpads and diapers.
3. Immediately dispose of tissues and underpads to control odor. Allow to dry. No rinsing necessary.
4. Apply protective ointment liberally as often as necessary with each diaper, garment, or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged.
5. Check patient often. Repeat steps 1-4 after each exposure to feces and urine.

QUESTIONS

Refer to individual product labeling for detailed instructions.

​Packaged in the USA with products made in USA and India for:

Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN England.

www.smith-nephew.com

Trademarks of Smith & Nephew

Certain marks reg'd U.S. Pat. & Tm. Off.

DRUG FACTS - SECURA◊ PERSONAL CLEANSER

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 the 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

• ​Keep out of reach of children. ​In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

• spray 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

DRUG FACTS - SECURA◊ PROTECTIVE OINTMENT

ACTIVE INGREDIENTS

Petrolatum 98.789%

PURPOSE

Skin protectant

USES

• skin protectant
• helps treat and prevent diaper dermatitis
• protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

• ​For external use only
• Avoid contact with the 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

• ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center immediately

DIRECTIONS

• change wet and soiled diapers, garments and linens promptly
• cleanse the affected area and allow to dry
• apply ointment liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT

#59434300
NDC 69740-343-00

Personal Skin Care Kit

Kit contains:

Antimicrobial Skin Cleanser

SECURA◊ Personal Cleanser

8 fl. oz. (236 mL)

• 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

Skin Protectant

SECURA◊ Protective Ointment

2.47 oz. (70 g)

• For treatment and prevention of incontinence-associated dermatitis
• Enriched with Vitamins A, D & E
• Pediatric tested
• CHG compatible
• Enriched with Clove Oil

Smith&Nephew

Secura◊

​Personal Skin Care Kit

PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT

#594343000

​NDC ​69740-343-00

​Personal Skin Care Kit

Kit Contains:

​Secura◊ Personal Cleanser8 fl. oz. (236 mL)

Secura◊ Protective Ointment 2.47 oz. (70 g)

Smith&Nephew
Secura◊
Personal Skin Care Kit

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-balanced
• Pediatric tested
• CHG compatible

Smith&Nephew
Secura◊
Personal Cleanser

8 fl oz. (236 mL)

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 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. ​In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

​DIRECTIONS​

• spray 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

​QUESTIONS OR COMMENTS?

​1 800 876-1261

Made in USA for:
Smith & Nephew Medical Ltd
101 Hessle Rd, 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 PROTECTIVE OINTMENT (70g)

#59431500
NDC 69740-315-00

Protective Ointment

Skin Protectant

• For treatment and prevention of incontinence-associated dermatitis
• Enriched with Vitamins A, D & E
• Pediatric tested
• CHG compatible
• Enriched with Clove Oil

Smith&Nephew
Secura ◊
Protective Ointment

Net  wt. 2.47 oz (70g)

DRUG FACTS

ACTIVE INGREDIENTS

​Petrolatum 98.789%

​PURPOSE

Skin protectant

USES
skin protectant
helps treat and prevent diaper dermatitis
protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS
For external use only
Avoid contact with the 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
change wet and soiled diapers, garments and linens promptly
cleanse the affected area and allow to dry
apply ointment liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261

Made in India for:
Smith & Nephew Medical Ltd

101 Hessle Rd, Hull HU3 2BN England

Trademark of Smith & Nephew

Certain marks reg'd U.S. Pat. and Tm. Off.

INGREDIENTS AND APPEARANCE

SECURA PERSONAL SKIN CARE KIT 
benzethonium chloride,petrolatum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-343

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-343-00	1 in 1 CARTON; Type 0: Not a Combination Product	08/01/2003

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, SPRAY	236 mL
Part 2	1 TUBE	70 g

Part 1 of 2

SECURA PERSONAL CLEANSER 
benzethonium chloride spray

Product Information
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 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	2 uL  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	3.08 ug  in 1 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	3 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	1 ug  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	1 ug  in 1 mL
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)	20 uL  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	10 ug  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)	171.3 ug  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E

Part 2 of 2

SECURA PROTECTIVE 
petrolatum ointment

Product Information
Item Code (Source)	NDC: 69740-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	987.89 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	5 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0)	3 mg  in 1 g
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)	0.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	2 mg  in 1 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	0.1 mg  in 1 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		70 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-America Products, Inc.		080170933	manufacture(69740-304, 69740-343)

Establishment
Name	Address	ID/FEI	Business Operations
ENCUBE ETHICALS PVT LTD		915834105	manufacture(69740-315)