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

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KIT 1 KIT in 1 CARTON (50484-343-00) * 236 mL in 1 BOTTLE, SPRAY * 70 g in 1 TUBE Label Information

Complete Secura Personal Skin Care Kit Information

  • DRUG FACTS - SECURA PERSONAL SKIN CARE KIT

    Kit information is followed by Drug Facts for the kit contents and related products.


  • 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.

  • QUESTIONS

    Refer to individual product labeling for detailed instructions.


  • DRUG FACTS - SECURA PERSONAL CLEANSER (236 mL)

    ACTIVE INGREDIENTS

    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 puncture wounds, infections, or lacerations 

    • If condition worsens or does not improve within 7 days, contact a doctor

    • Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

    DIRECTIONS
    • spray/apply cleanser liberally on affected area, then wipe clean
    • no rinsing necessary 

    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

    QUESTION OR COMMENTS?

    1 800 876-1261


  • DRUG FACTS - SECURA PROTECTIVE OINTMENT (70 g)

    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


  • PRINCIPAL DISPLAY PANEL


    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT

    #59434300
    NDC 50484-343-00

    Personal Skin Care Kit

    Kit contains:

    • Antimicrobial Skin Cleanser
    • Skin Protectant

    Smith&Nephew
    Securaâ—Š
    Personal Skin Care Kit


    Kit Contains:
    Securaâ—Š Personal Cleanser
    8 fl. oz. (236mL)

    Securaâ—Š Protective Ointment
    2.47 oz. (70g)


    Personal
    Skin Care Kit

    Good skin care can  help prevent breakdown

    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.

    Package Display - Kit



  • PRINCIPAL DISPLAY PANEL

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

    #59430400
    NDC 50484-304-00

    Personal Cleanser

    Antimicrobial Skin Cleanser

    • No-rinse, one-step cleansing for perineum or body
    • Gentle surfactants emulsify stool without friction
    • Reduces odor
    • pH-buffered
    • Pediatrician tested

    Smith&Nephew
    Securaâ—Š
    Personal Cleanser

    8 fl oz. (236mL)


    Made for:
    Smith & Nephew, Inc.
    St. Petersburg, FL 33716
    www.smith-nephew.com
    Trademark of Smith & Nephew.
    Reg. U.S. Pat. & Tm. Off.


    Package Display - Personal Cleanser (236 mL)



  • PRINCIPAL DISPLAY PANEL

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

    #59431500
    NDC 50484-315-00

    Protective Ointment

    Skin Protectant

    • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
    • Contains Vitamins A, D & E
    • Clove Oil controls odor
    • Pediatrician tested

    Smith&Nephew
    Securaâ—Š
    Protective Ointment

    Net  wt. 2.47 oz (70g)


    Made in India for:
    Smith & Nephew, Inc., St. Petersburg, FL 33716
    Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.

    Package Display - Protective Ointment (70g)



  • INGREDIENTS AND APPEARANCE
    SECURA PERSONAL SKIN CARE KIT 
    benzethonium chloride,petrolatum kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-343
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-343-00 1 in 1.0 CARTON; Type 1: Convenience Kit of Co-Package 08/01/2003 01/31/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, SPRAY 236 mL
    Part 2 1 TUBE 70 g
    Part 1 of 2
    SECURA PERSONAL CLEANSER 
    benzethonium chloride spray
    Product Information
    Item Code (Source) NDC:50484-304
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL  in 1 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 3.08 ug  in 1 mL
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 3 ug  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 ug  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 10 ug  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 10 ug  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 Code Package Description Marketing Start Date Marketing End Date
    1 236 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
    Part 2 of 2
    SECURA PROTECTIVE 
    petrolatum ointment
    Product Information
    Item Code (Source) NDC:50484-315
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 987.89 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 70 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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 01/31/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 MANUFACTURE(50484-343, 50484-304)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE(50484-315)