SECURA EPC SKIN CARE STARTER KIT- zinc oxide,benzethonium chloride 
Smith & Nephew, Inc.

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 EPC Skin Care Starter Kit

DRUG FACTS - SECURA EPC SKIN CARE STARTER KIT

Refer to individual product labeling for detailed instructions.

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 59oF-86oF (15oC-30oC)

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

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 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,
D&C Blue #1

QUESTIONS OR COMMENTS?

1 800 876-1261

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

#59434100

NDC 50484-341-00

EPC Skin Care Starter Kit

Antimicrobial Skin Cleanser

Secura Moisturizing Cleanser 4 fl. oz.  (118mL)

  • Provides one-step no-rinse cleansing for perineum and body; saves time
  • Pediatrician-tested

Skin Protectant

Secura Extra Protective Cream 3.25 oz.  (92g)

  • Helps treat and prevent diaper dermatitis
  • Contains Karaya to adhere to macerated skin

Packaged in the USA with products made in USA and India for:

Smith & Nephew, Inc.

St. Petersburg, FL 33716

www.smith-nephew.com

Trademarks of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.


Smith&Nephew
Secura◊
EPC Skin Care Starter Kit

Package Display - EPC Skin Care Starter Kit


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

Item #59432400

NDC 50484-324-00

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
  • Resists wash-off
  • Pediatrician tested

Smith & Nephew

Secura◊

Extra Protective Cream


Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716

www.smith-nephew.com

Trademark of Smith & Nephew Reg. U.S. Pat. & Tm. Off.


Package Display - Extra Protective Cream Tube (92g)

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

Item #59430800

NDC 50484-308-00

Moisturizing Cleanser

Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces Odor
  • pH-balanced
  • Contains Aloe and Glycerin to condition, soothe and moisturize skin
  • Pediatrician-tested

Smith & Nephew

Secura◊

Moisturizing Cleanser

Made for:
Smith & Nephew, Inc., St. Petersburg, FL 33773
www.smith-nephew.com
Trademark of Smith & Nephew Reg. U.S. Pat. & Tm. Off.

Package Display - Moisturizing Cleanser Bottle (118mL)

SECURA EPC SKIN CARE STARTER KIT 
zinc oxide,benzethonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-341
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-341-001 in 1.0 CONTAINER; Type 1: Convenience Kit of Co-Package08/01/200307/30/2018
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:50484-324
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION306.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
KARAYA GUM (UNII: 73W9IQY50Q)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
192 g in 1.0 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/200307/30/2018
Part 2 of 2
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:50484-308
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
ALOE (UNII: V5VD430YW9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200307/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/200307/30/2018
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-324, 50484-341)
Establishment
NameAddressID/FEIBusiness Operations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE(50484-341)

Revised: 7/2016
Document Id: 1c69f85f-2aa6-4fb5-b266-be41d5bee0f2
Set id: cfcb4fd2-87d0-4fa4-8b5c-24a2424577a2
Version: 10
Effective Time: 20160722
 
Smith & Nephew, Inc.