SECURA TWO STEP KIT- benzethonium chloride and zinc oxide cream 
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 Two Step Kit

#59434400
NDC 69740-344-00

Two-Step Kit

DIRECTIONS

Good skin care can help prevent breakdown.

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 cream 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.

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◊ MOISTURIZING CLEANSER

ACTIVE INGREDIENTS

Benzethonium chloride 0.13%

PURPOSE

Antimicrobial

USES

WARNINGS

For external use only

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

INACTIVE INGREDIENTS

water, polysorbate 20, glycerin, polyquaternium-10, benzyl alcohol, fragrance, disodium EDTA, aloe barbadensis, FD&C Blue #1

DRUG FACTS - SECURA◊ PROTECTIVE CREAM

ACTIVE INGREDIENTS

Zinc oxide 10%

PURPOSE

Skin protectant

USES

WARNINGS

For external use only

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

INACTIVE INGREDIENTS

water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis

QUESTIONS OR COMMENTS?

1 800 876-1261

PACKAGE LABEL (Front)

#59434400
NDC 69740-344-00

Two-Step Kit
Kit contains:

Antimicrobial Skin Cleanser

SECURA◊ Moisturizing Cleanser

8 fl. oz. (236 mL)

Skin Protectant

SECURA◊ Protective Cream

2.75 oz. (78g)

smith&nephew

SECURA◊

Two-Step Kit

PACKAGE LABEL (Side)

Two-Step Kit

Kit contains:


SECURA◊ Moisturizing Cleanser

8 fl. oz. (236 mL)

SECURA◊ Protective Cream

2.75 oz. (78 g)

smith&nephew

SECURA◊

Two-Step Kit

Two Step Kit Front Label

PACKAGE LABEL - SECURA MOISTURIZING CLEANSER

Item #59430900
NDC 69740-309-00

Moisturizing
Cleanser

Antimicrobial Skin Cleanser

Smith&Nephew
Secura Moisturizing Cleanser

8 fl. oz. (236mL)


DRUG FACTS


ACTIVE INGREDIENT

Benzethonium chloride 0.13%

PURPOSE

Antimicrobial

USES

WARNINGS

For external use only

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

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. & Tm. Off.

Cleanser Label 236 mL

PACKAGE DISPLAY PANEL - SECURA PROTECTIVE CREAM

Item #59431200
NDC 69740-312-00

Protective Cream

Skin Protectant

Smith & Nephew
Secura Protective Cream

New wt. 2.75 oz. (78 g)

DRUG FACTS - SECURA PROTECTIVE CREAM

ACTIVE INGREDIENT

Zinc oxide 10%

PURPOSE

Skin protectant

USES

WARNINGS

For external use only

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

INACTIVE INGREDIENTS

water, petrolatum, cetearyl alcohol, PEG-40 caster oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis

QUESTIONS OR COMMENTS?

1 800 867-1261

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. & Tm. Off.

Protective Cream 78 g

SECURA TWO STEP KIT 
benzethonium chloride and zinc oxide cream kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-344
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69740-344-001 in 1 CARTON08/01/2003
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 236 mL
Part 21 TUBE 78 g
Part 1 of 2
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:69740-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL  in 1 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 ug  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.05 ug  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
WATER (UNII: 059QF0KO0R) 945.94 uL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1236 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2003
Part 2 of 2
SECURA PROTECTIVE 
zinc oxide cream
Product Information
Item Code (Source)NDC:69740-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 597.125 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 89 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) 2 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0) 2 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg  in 1 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 10 mg  in 1 g
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 7 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) 150 mg  in 1 g
ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.375 mg  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
178 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2003
Labeler - Smith & Nephew, Medical Ltd. (216344051)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-America Products, Inc.080170933manufacture(69740-309, 69740-344)
Establishment
NameAddressID/FEIBusiness Operations
ENCUBE ETHICALS PVT LTD915834105manufacture(69740-312)

Revised: 12/2017
Document Id: 604d4385-1c99-4316-e053-2a91aa0ae702
Set id: 92e2a1b5-a5ca-4224-a5db-539e3c43d241
Version: 8
Effective Time: 20171214
 
Smith & Nephew, Medical Ltd.