Label: SECURA PROTECTIVE- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 2, 2017

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, cholecalciferold, D&C Green #6

  • QUESTIONS OR COMMENTS?

    1 800 876-1261

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (3.5 g)

    #59434800

    NDC-69740-315-01

    Protective Ointment

    Skin Protectant

    • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
    • Contains Vitamins A, D & E
    • Moisturizes and conditions
    • Clove Oil controls odor
    • Pediatrician tested

    Smith&Nephew 

    Secura◊

    Protective Ointment

    Net wt. 0.12 oz (3.5 g)

    Made in the USA for:

    Smith & Nephew Medical Ltd,

    101 Hessle Road, Hull, HU3 2BN, England

    Trademark of Smith & Nephew. Certain marks Reg'd U.S. Pat. & Tm. Off.

    3-5g

  • INGREDIENTS AND APPEARANCE
    SECURA PROTECTIVE 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM987.89 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 5 mg  in 1 g
    CLOVE OIL (UNII: 578389D6D0) 3 mg  in 1 g
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7) 0.01 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg  in 1 g
    CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.1 mg  in 1 g
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-315-013.5 g in 1 POUCH; Type 0: Not a Combination Product08/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2003
    Labeler - Smith & Nephew Medical Ltd (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO LLC080170933MANUFACTURE(69740-315)