FDA.reportPublic FDA data

Secura Protective Ointment

Manufacturer
Smith & Nephew Medical Ltd | Swiss-American CDMO LLC
Effective date
2017-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:14:22

Label at a glance#

ProductSecura Protective
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

Skin protectant Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 98.789%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • Skin protectant
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferold, D&C Green #6

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#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.

3-5g3-5g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-315-012024-08-23C16284748780-11030e365-4add-111a-e063-dadaa90a10e2Secura Protective Ointment
69740-315-012024-01-30C16284748780-11030e365-4add-111a-e063-dadaa90a10e2Secura Protective Ointment

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-31569740-315-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CLOVE OIL578389D6D0IACT
D&C GREEN NO. 64QP5U84YF7IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CORN OIL8470G57WFMIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20082be1-e14c-7194-e063-6294a90ab405194e14dd-cb5f-48ca-bee9-abbb1c43a9ea2024-08-19WarningsExact identifier
spl set id: 194e14dd-cb5f-48ca-bee9-abbb1c43a9ea
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
ndc (product): 69740-315

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.