SECURA PERSONAL SKIN CARE KIT- benzethonium chloride,petrolatum 
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 Personal Skin Care Kit

​#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.

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

WARNINGS

DIRECTIONS

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

WARNINGS

DIRECTIONS

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)

Skin Protectant

SECURA◊ Protective Ointment

2.47 oz. (70 g)


Smith&Nephew

Secura◊

​Personal Skin Care Kit

Secura Carton Main Panel

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

Secura Carton Side Panel

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

#59430400

​NDC ​69740-304-00

​Personal Cleanser

Antimicrobial Skin Cleanser

Smith&Nephew
Secura◊
Personal Cleanser


8 fl oz. (236 mL)

DRUG FACTS

ACTIVE INGREDIENT

​Benzethonium chloride 0.13%

​PURPOSE

​Antimicrobial

​USES

​WARNINGS

​DIRECTIONS

​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.

236 mL Cleanser

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70g)

#59431500
NDC 69740-315-00

Protective Ointment

Skin Protectant

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.

70g Ointment

SECURA PERSONAL SKIN CARE KIT 
benzethonium chloride,petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-343
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69740-343-001 in 1 CARTON; Type 0: Not a Combination Product08/01/2003
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 236 mL
Part 21 TUBE 70 g
Part 1 of 2
SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:69740-304
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
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 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 finalpart333E
Part 2 of 2
SECURA PROTECTIVE 
petrolatum ointment
Product Information
Item Code (Source)NDC:69740-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM987.89 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
170 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 finalpart347
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(69740-304, 69740-343)
Establishment
NameAddressID/FEIBusiness Operations
ENCUBE ETHICALS PVT LTD915834105manufacture(69740-315)

Revised: 12/2017
Document Id: 604d4385-1c7c-4316-e053-2a91aa0ae702
Set id: eba485f5-b9b0-4580-987d-42354df4810c
Version: 3
Effective Time: 20171214
 
Smith & Nephew Medical Ltd