SECURA STARTER KIT- benzethonium chloride,petrolatum kit

Secura Starter Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

#59434200

NDC: 69740-342-00

Starter 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.
6. Moisturize skin daily and after bathing to prevent dryness.

Refer to individual product labeling for detailed instructions.

Packaged in the USA with products made in the 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. and Tm. Off.

DRUG FACTS - SECURA MOISTURIZING 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

WARNING

• 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, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• apply cleanser liberally on the 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

DRUG FACTS - SECURA PROTECTIVE OINTMENT ACTIVE INGREDIENT

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 STARTER KIT

#59434200
NDC 69740-342-00

Starter Kit

Kit Contains:

Antimicrobial Skin Cleanser

Secura Moisturizing 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-buffered
Pediatric tested
CHG compatible

Skin Protectant

Secura Protective Ointment
2.47 oz (70 g)
For treatment and prevention of incontinence-associated dermatitis
Emriched with Vitamins A, D, & E
Pediatric tested
CHG compatible
Enriched with Clove Oil

Moisturizer
Secura Moisturizing Cream
3 fl oz (85 g)
Nourishes, hydrates and restores moisture to dry skin
Enriched with Vitamin E
Absorbs quickly, non-greasy
Fortifies moisture balance
Lanolin-free
CHG compatible

Smith&Nephew
Secura
Starter Kit

PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA STARTER KIT

#59434200
NDC 69740-342-00

Starter Kit

Kit contains

Antimicrobial Skin Cleanser

Secura Moisturizing Cleanser
8 fl. oz. (236 mL)

Skin Protectant

Secura Protective Ointment
2.47 oz. (70 g)

Moisturizer

Secura Moisturizing Cream
3 fl. oz (85 g)

Smith&Nephew
Secura
Starter Kit

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

Item #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)

DRUG FACTS - SECURA? MOISTURIZING 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 eyes

Not to be applied over deep or puncture wounds, infections, or lacerations

If condition worsens or does not improve within 7 days, consult 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

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 - TUBE (70 g)

Item #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. (70 g)

DRUG FACTS

ACTIVE INGREDIENT

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 STARTER KIT 
benzethonium chloride,petrolatum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-342

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-342-00	1 in 1 KIT	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 MOISTURIZING CLEANSER 
benzethonium chloride spray

Product Information
Item Code (Source)	NDC: 69740-309
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
ALOE VERA FLOWER (UNII: 575DY8C1ER)	0.05 ug  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	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 ug  in 1 mL
WATER (UNII: 059QF0KO0R)	945.94 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.2 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-American Products, Inc.		080170933	manufacture(69740-309, 69740-342)

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