Label: SECURA EXTRA PROTECTIVE- zinc oxide cream
SECURA EXTRA PROTECTIVE CREAM- zinc oxide cream

  • NDC Code(s): 69740-324-00, 69740-325-00
  • Packager: Smith & Nephew Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • ACTIVE INGREDIENT

    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 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 Certer immediately

    • Avoid contact with eyes

    • Not to be appliedover deep or puncture wounds, infections, or lacerations

    • If condition worsensor 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 59 oF-86 oF (15 oC-30 oC)

  • 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

  • PRINCIPAL DISPLAY PANEL

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

    Item #59432400

    NDC 69740-324-00

    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
    • Pediatric tested
    • CHG compatible

    Smith & Nephew

    Secura

    Extra Protective Cream

    Made in India for
    Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England

    Trademark of Smith & Nephew

    Certain marks reg'd U.S. Pat. and Tm. Off.

    92grams-secura-label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g)

    Item #59432500

    NDC69740-325-00

    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
    • Pediatric tested
    • CHG compatible


    Smith & Nephew

    Secura◊

    Extra Protective Cream

    Made in India for
    Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England

    ◊Trademark of Smith & Nephew

    Certain marks reg'd U.S. Pat. and Tm. Off.

    219grams-secura-label

  • INGREDIENTS AND APPEARANCE
    SECURA EXTRA PROTECTIVE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION306.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-324-0092 g in 1 TUBE; Type 0: Not a Combination Product08/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/01/2003
    SECURA EXTRA PROTECTIVE CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE306.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-325-00219 g in 1 TUBE; Type 0: Not a Combination Product08/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/01/2003
    Labeler - Smith & Nephew Medical Ltd (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENCUBE ETHICALS PVT LTD725076298manufacture(69740-324, 69740-325)