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Secura Protective (Smith & Nephew, Inc.)

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CREAM 50 g in 1 TUBE (50484-311-00) Label Information

Complete Secura Protective Information

  • DRUG FACTS


  • 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 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, garmet 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


  • QUESTION OR COMMENTS?

    1 800 876-1261


  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

    Item #59431100

    NDC 50484-311-00

    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

    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 - Tube (50g)


  • INGREDIENTS AND APPEARANCE
    SECURA PROTECTIVE 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG 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
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 89 mg  in 1 g
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-312-00 78 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 07/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 07/31/2020
    SECURA PROTECTIVE 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-311
    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
    ALLANTOIN (UNII: 344S277G0Z) 2 mg  in 1 g
    ALOE (UNII: V5VD430YW9) 0.375 mg  in 1 g
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 7 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
    WATER (UNII: 059QF0KO0R) 597.125 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 150 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 89 mg  in 1 g
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-311-00 50 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 07/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 07/31/2020
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE(50484-311, 50484-312)