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Secura Starter Kit

Dosage form: kit
Ingredients: BENZETHONIUM CHLORIDE 1.3ug in 1mL; PETROLATUM 987.89mg in 1g
Labeler: Smith & Nephew Medical Ltd
NDC Code: 69740-342

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.

Secura Starter Kit

#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. 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. 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.

SECURA STARTER KIT 
benzethonium chloride,petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-342
Packaging
#Item CodePackage Description
1NDC:69740-342-001 KIT in 1.0 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 236 mL
Part 21 TUBE 70 g
Part 1 of 2
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:69740-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA FLOWER0.05 ug  in 1 mL
BENZYL ALCOHOL2 uL  in 1 mL
FD&C BLUE NO. 10.001 uL  in 1 mL
GLYCERIN10 uL  in 1 mL
POLYSORBATE 2030 ug  in 1 mL
WATER945.94 uL  in 1 mL
EDETATE DISODIUM0.2 ug  in 1 mL
Packaging
#Item CodePackage Description
1236 mL in 1.0 BOTTLE, SPRAY
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM987.89 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL5 mg  in 1 g
CLOVE OIL3 mg  in 1 g
D&C GREEN NO. 60.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CHOLECALCIFEROL0.1 mg  in 1 g
VITAMIN A PALMITATE 
CORN OIL 
Packaging
#Item CodePackage Description
170 g in 1.0 TUBE
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/FEIOperations
Swiss-American Products, Inc.611921669MANUFACTURE(69740-309), manufacture(69740-342)
Establishment
NameAddressID/FEIOperations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE(69740-315)

Revised: 04/2016
 
Smith & Nephew Medical Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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