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Secura Extra Protective (Smith & Nephew, Inc.)

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CREAM 92 g in 1 TUBE (50484-324-00) Label Information

Complete Secura Extra Protective Information

  • DRUG FACTS


  • ACTIVE INGREDIENTS

    Zinc Oxide 30.6%


  • 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 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


  • QUESTION OR COMMENTS?

    1 800 876-1261


  • PRINCIPAL DISPLAY PANEL


    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- 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 - Tube (92g)



  • INGREDIENTS AND APPEARANCE
    SECURA EXTRA PROTECTIVE 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-325
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 306.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 30.6 mg  in 1 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 1.3 mg  in 1 g
    BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.5 mg  in 1 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 2 mg  in 1 g
    KARAYA GUM (UNII: 73W9IQY50Q) 71.4 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 3.1 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 41 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 408.2 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 21.6 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 61.2 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-325-00 219.7 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 08/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 08/31/2018
    SECURA EXTRA PROTECTIVE 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG 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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 306.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 30.6 mg  in 1 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 1.3 mg  in 1 g
    BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.5 mg  in 1 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 2 mg  in 1 g
    KARAYA GUM (UNII: 73W9IQY50Q) 71.4 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 3.1 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 41 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 408.2 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 21.6 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 61.2 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-324-00 92 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 08/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2003 08/31/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE(50484-324, 50484-325)