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Secura EPC Skin Care Starter Kit

Dosage form: kit
Ingredients: ZINC OXIDE 306.1mg in 1g; BENZETHONIUM CHLORIDE 1.3ug in 1mL
Labeler: Smith & Nephew Medical Ltd
NDC Code: 69740-341

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 EPC Skin Care Starter Kit

​#59434100

NDC 69740-341-00

EPC Skin Care 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 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 unrine 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. 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 and 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. If swallowed, get medical help or contact a Poison Control Center immediately

DIRECTIONS

• apply 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

DRUG FACTS - SECURA◊ EXTRA PROTECTIVE CREAM

ACTIVE INGREDIENT

Zinc Oxide 30.6%

PURPOSE

Skin protectant

USES

• 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 cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged

OTHER INFORMATION

Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)

INACTIVE INGREDIENTS

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT

#59434100


NDC 69740-341-00


EPC Skin Care Starter Kit


Kit contains:


Antimicrobial Skin Cleanser

Secura◊ Moisturizing Cleanser

4 fl. oz. (118 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◊ Extra Protective Cream

3.25 oz. (92 g)
• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible

Smith&Nephew
Secura
EPC Skin Care Starter Kit

PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT

#59434100


NDC 69740-341-00


EPC Skin Care Starter Kit


Kit contains:


Secura◊ Moisturizing Cleanser

4 fl. oz. (118 mL)


Secura◊ Extra Protective Cream

3.25 oz. (92 g)

Smith&Nephew
Secura
EPC Skin Care Starter Kit

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EXTRA PROTECTIVE CREAM - TUBE (92 g)

Item #59432400


NDC 69740-324-00


Extra Protective Cream


Skin Protectant
• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible


Smith & Nephew


Secura


Extra Protective Cream

Net wt. 3.25 oz. (92 g)

DRUG FACTS

ACTIVE INGREDIENT

​Zinc Oxide 30.6%

​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 cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged

​OTHER INFORMATION

Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)

​INACTIVE INGREDIENTS

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

​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.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER - BOTTLE (118 mL)

Item #59430800


NDC 69740-308-00


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


4 fl. oz. (118 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 and 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. 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 the USA for Smith & Nephew 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.

SECURA EPC SKIN CARE STARTER KIT 
zinc oxide, benzethonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-341
Packaging
#Item CodePackage Description
1NDC:69740-341-001 KIT in 1 CONTAINER
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 92 g
Part 21 BOTTLE, SPRAY 118 mL
Part 1 of 2
SECURA EXTRA PROTECTIVE 
zinc oxide cream
Product Information
Item Code (Source)NDC:69740-324
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION306.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE30.6 mg  in 1 g
WATER21.6 mg  in 1 g
PETROLATUM408.2 mg  in 1 g
MINERAL OIL41 mg  in 1 g
METHYLPARABEN3.1 mg  in 1 g
KARAYA GUM71.4 mg  in 1 g
DIAZOLIDINYL UREA2 mg  in 1 g
BUTYLPARABEN0.5 mg  in 1 g
BENZETHONIUM CHLORIDE1.3 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CETOSTEARYL ALCOHOL61.2 mg  in 1 g
Packaging
#Item CodePackage Description
192 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart347
Part 2 of 2
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:69740-308
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
ALOE0.05 ug  in 1 mL
BENZYL ALCOHOL2 uL  in 1 mL
EDETATE DISODIUM0.2 ug  in 1 mL
FD&C BLUE NO. 10.001 ug  in 1 mL
GLYCERIN10 ug  in 1 mL
POLYSORBATE 2030 ug  in 1 mL
WATER945.94 uL  in 1 mL
Packaging
#Item CodePackage Description
1118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E
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-America Products, Inc.080170933manufacture(69740-308, 69740-341)
Establishment
NameAddressID/FEIOperations
ENCUBE ETHICALS PVT LTD915834105manufacture(69740-324)

 
Smith & Nephew Medical Ltd

Medically reviewed on Dec 14, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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