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Secura Two Step Kit (Smith & Nephew, Inc.)

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KIT 1 KIT in 1 CARTON (50484-344-00) * 236 mL in 1 BOTTLE, SPRAY * 78 g in 1 TUBE Label Information

Complete Secura Two Step Kit Information

  • DRUG FACTS - Secura Two Step Kit

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


  • DIRECTIONS

    Good skin care can help prevent breakdown.

    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 urine 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.


  • DRUG FACTS - SECURA MOISTURIZING CLEANSER


  • ACTIVE INGREDIENTS

    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


  • QUESTION OR COMMENTS?

    1 800 876-1261


  • DRUG FACTS - SECURA PROTECTIVE CREAM


  • ACTIVE INGREDIENTS

    Zinc oxide 10%


  • 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 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, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged

  • INACTIVE INGREDIENTS

    water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis


  • QUESTIONS

    1 800 876-1261


  • PACKAGE LABEL - Secura Two Step Kit

    #59434400
    NDC 50484-344-00

    Two-Step Kit
    Kit contains:

    • Antimicrobial Skin Cleanser
    • Skin Protectant

    smith&nephew
    SECURAâ—ŠTwo-Step Kit

    Kit contains:

    SECURAâ—Š Moisturizing Cleanser
    8 fl. oz. (236mL)

    SECURAâ—Š Protective Cream
    2.75 oz. (78g)

    Two-Step 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 - Two-step-kit


  • PACKAGE LABEL - SECURA MOISTURIZING CLEANSER

    Item #59430900
    NDC 50484-309-00

    Moisturizing
    Cleanser

    Antimicrobial Skin Cleanser

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

    Smith&Nephew
    Securaâ—Š
    Moisturizing 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 - Moisturizing Cleanser-236ml



  • PACKAGE DISPLAY PANEL - SECURA PROTECTIVE CREAM

    Item #59431200
    NDC 50484-312-00

    Protective Cream

    Skin Protectant

    • For treatment and prevention of dermatitis associated with exposure to feces or urine
    • Contains Allantoin and Vitamin E
    • Clove Oil controls odor
    • Conditions and soothes
    • Pediatrician tested

    Smith & Nephew
    Securaâ—Š
    Protective Cream

    2.75 oz. (78g)

    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 - Protective-Cream-78g


  • INGREDIENTS AND APPEARANCE
    SECURA TWO STEP KIT 
    benzethonium chloride and zinc oxide kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-344
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-344-00 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 08/01/2003 01/31/2020
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, SPRAY 236 mL
    Part 2 1 TUBE 78 g
    Part 1 of 2
    SECURA MOISTURIZING CLEANSER 
    benzethonium chloride spray
    Product Information
    Item Code (Source) NDC:50484-309
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 ug  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
    ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.05 ug  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
    WATER (UNII: 059QF0KO0R) 945.94 uL  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 236 mL in 1 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 
    zinc oxide cream
    Product Information
    Item Code (Source) NDC:50484-312
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R) 597.125 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 89 mg  in 1 g
    ALLANTOIN (UNII: 344S277G0Z) 2 mg  in 1 g
    CLOVE OIL (UNII: 578389D6D0) 2 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg  in 1 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 10 mg  in 1 g
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 7 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 150 mg  in 1 g
    ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.375 mg  in 1 g
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 78 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 01/31/2020
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 MANUFACTURE(50484-344, 50484-309)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE(50484-312)