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Secura EPC Skin Care Starter Kit (Smith & Nephew, Inc.)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CONTAINER (50484-341-00) * 92 g in 1 TUBE * 118 mL in 1 BOTTLE, SPRAY Label Information

Complete Secura EPC Skin Care Starter Kit Information

  • 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


  • PRINCIPAL DISPLAY PANEL

    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
    Securaâ—Š
    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

    Securaâ—Š

    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

    Securaâ—Š

    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)


  • INGREDIENTS AND APPEARANCE
    SECURA EPC SKIN CARE STARTER KIT 
    zinc oxide,benzethonium chloride kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-341
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-341-00 1 in 1.0 CONTAINER; Type 1: Convenience Kit of Co-Package 08/01/2003 07/30/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 92 g
    Part 2 1 BOTTLE, SPRAY 118 mL
    Part 1 of 2
    SECURA EXTRA PROTECTIVE 
    zinc oxide cream
    Product Information
    Item Code (Source) NDC:50484-324
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 306.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 92 g in 1.0 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 07/30/2018
    Part 2 of 2
    SECURA MOISTURIZING CLEANSER 
    benzethonium chloride spray
    Product Information
    Item Code (Source) NDC:50484-308
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1.3 ug  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 118 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 08/01/2003 07/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 08/01/2003 07/30/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 MANUFACTURE(50484-324, 50484-341)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE(50484-341)