Label: SECURA PROTECTIVE- petrolatum ointment

  • NDC Code(s): 50484-315-00, 50484-315-01, 50484-316-00
  • Packager: Smith & Nephew, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/10

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

  • DRUG FACTS

    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

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  • 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
    Secura
    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 (3.5g)


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  • INGREDIENTS AND APPEARANCE
    SECURA PROTECTIVE 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50484-315
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 987.89 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL 5 mg  in 1 g
    CLOVE OIL 3 mg  in 1 g
    D&C GREEN NO. 6 0.01 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE 2 mg  in 1 g
    CHOLECALCIFEROL 0.1 mg  in 1 g
    VITAMIN A PALMITATE  
    CORN OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-315-00 70 g in 1.0 TUBE
    2 NDC:50484-315-01 150 in 1 BOX
    2 3.5 g in 1.0 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 08/01/2003
    SECURA PROTECTIVE 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50484-316
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 987.89 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL 5 mg  in 1 g
    CLOVE OIL 3 mg  in 1 g
    D&C GREEN NO. 6 0.01 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE 2 mg  in 1 g
    CHOLECALCIFEROL 0.1 mg  in 1 g
    VITAMIN A PALMITATE  
    CORN OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-316-00 159 g in 1.0 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 08/01/2003
    Labeler - Smith & Nephew, Inc. (827731451)
    Registrant - ENCUBE ETHICALS PVT LTD (915834105)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 MANUFACTURE
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