FDA.reportPublic FDA data

Secura Protective Ointment

Manufacturer
Smith & Nephew Medical Ltd | ENCUBE ETHICALS PVT LTD
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:16:56

Label at a glance#

ProductSecura Protective
Active ingredientPETROLATUM
Label structure10 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 98.849%

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 worsensor 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, tocopheryl acetate, butylparaben, 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 (70g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

69740-31569740-315#59431500

NDC-69740-315-00

Protective Ointment

Skin Protectant

  • For treatment and prevention of incontinence-associated dermatitis
  • Enriched with Vitamins A, D & E
  • Pediatric tested
  • CHG compatible
  • Enriched with Clove Oil

Smith&Nephew

Secura

Protective Ointment

Net wt. 2.47 oz (70 g)

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. & Tm. Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (159g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

69740-31669740-316#59431600

NDC-69740-316-00

Protective Ointment

Skin Protectant

For treatment and prevention of incontinence-associated dermatitis
Enriched with Vitamins A, D & E
Pediatric tested
CHG compatible
Enriched with Clove Oil

Smith&Nephew
Secura
Protective Ointment


Net wt. 5.6 oz (159 g)

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. & Tm. Off.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581802petrolatum 98.8 % Topical OintmentPSN11
581802petrolatum 0.988 MG/MG Topical OintmentSCD11
581802petrolatum 98.8 % Topical OintmentSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-315-002024-03-27C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment
69740-316-002024-03-27C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment
69740-315-002024-01-30C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment
69740-316-002024-01-30C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-315-00Secura Protective70 g in 1 TUBEOINTMENT7011
69740-316-00Secura Protective159 g in 1 TUBEOINTMENT15911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-315SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]11Current NDC, Legacy NDC, 1 package rows20240809_20906566-fbf2-46d9-a5d8-c7f7356d1080.zip
69740-316SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]11Current NDC, Legacy NDC, 1 package rows20240809_20906566-fbf2-46d9-a5d8-c7f7356d1080.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF412
CLOVE OILINACTIVE INGREDIENT578389D6D02
CORN OILINACTIVE INGREDIENT8470G57WFM2
D&C GREEN NO. 6INACTIVE INGREDIENT4QP5U84YF72
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-31569740-315-00
69740-31669740-316-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLPARABEN3QPI1U3FV8IACT
BENZYL ALCOHOLLKG8494WBHIACT
CLOVE OIL578389D6D0IACT
D&C GREEN NO. 64QP5U84YF7IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CORN OIL8470G57WFMIACT
PETROLATUM4T6H12BN9UACTIB
BUTYLPARABEN3QPI1U3FV8IACT
BENZYL ALCOHOLLKG8494WBHIACT
CLOVE OIL578389D6D0IACT
D&C GREEN NO. 64QP5U84YF7IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CORN OIL8470G57WFMIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
ndc (package): 69740-315-00
ndc (package): 69740-316-00
ndc (product): 69740-315
ndc (product): 69740-316
ndc11 (package): 69740031500
ndc11 (package): 69740031600
spl id: 1e9fedee-d49d-2539-e063-6394a90a05bd
spl set id: 20906566-fbf2-46d9-a5d8-c7f7356d1080

Reported adverse events (FAERS/openFDA)#

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