FDA.reportPublic FDA data

Secura Protective Cream

Manufacturer
Smith & Nephew Medical Ltd | ENCUBE ETHICALS PVT LTD
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
153
Source
full-release
Hydrated at
2026-06-01 00:13:35

Label at a glance#

ProductSecura Protective
Active ingredientZINC OXIDE
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 cream 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 INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 10%

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 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

OTC - WHEN USING SECTION

  • Avoid contact with eyes

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

  • 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

  • Keep out of reach of children.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 cream 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

water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, propylparaben, aloe barbadensis

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REF 59431100

NDC69740-311-00

Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-asssociated dermatitis
  • Pediatric tested
  • CHG compatible
  • Enriched with Allantoin, Vitamin E and Aloe
  • Clove Oil controls odor
  • Conditions and soothes

Smith & Nephew

Secura ◊

Protective Cream

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

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

5943110059431100

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REF 59431200

NDC69740-312-00

Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-asssociated dermatitis
  • Pediatric tested
  • CHG compatible
  • Enriched with Allantoin, Vitamin E and Aloe
  • Clove Oil controls odor
  • Conditions and soothes

Smith & Nephew

Secura ◊

Protective Cream

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

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

5943120059431200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248279zinc oxide 10 % Topical CreamPSN153
248279zinc oxide 100 MG/ML Topical CreamSCD153
248279zinc oxide 10 % Topical CreamSY153
248279ZNO 100 MG/ML Topical CreamSY153

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-311-002024-03-13C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream
69740-312-002024-03-13C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream
69740-311-002024-01-30C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream
69740-312-002024-01-30C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-311-00Secura Protective50 g in 1 TUBECREAM50153
69740-312-00Secura Protective78 g in 1 TUBECREAM78153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-311SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]153Current NDC, Legacy NDC, 1 package rows20240614_b077aa64-49a3-42ee-abb3-88f833635b93.zip
69740-312SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]153Current NDC, Legacy NDC, 1 package rows20240614_b077aa64-49a3-42ee-abb3-88f833635b93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-312-00GM - Gram69740-312ac89215f-6eaa-4226-8883-098b7a86f08812022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOEINACTIVE INGREDIENTV5VD430YW91
ALOE VERA FLOWERINACTIVE INGREDIENT575DY8C1ER1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CLOVE OILINACTIVE INGREDIENT578389D6D01
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4B1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-31169740-311-00
69740-31269740-312-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 207T1F30V5YHIACT
OCTYL STEARATE772Y4UFC8BIACT
WATER059QF0KO0RIACT
ALLANTOIN344S277G0ZIACT
CLOVE OIL578389D6D0IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 40 CASTOR OIL4ERD2076EFIACT
ZINC OXIDESOI2LOH54ZACTIM
OCTYL PALMITATEUYY8LE6Q5YIACT
DIOCTYL ADIPATE2BD76YG9SIIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALLANTOIN344S277G0ZIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
CLOVE OIL578389D6D0IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIOCTYL ADIPATE2BD76YG9SIIACT
OCTYL PALMITATEUYY8LE6Q5YIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTYL STEARATE772Y4UFC8BIACT

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 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact 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
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CETOSTEARYL SULFATESODIUM CETOSTEARYL SULFATE7ZBS06BH4BCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CETOSTEARYL SULFATESODIUM CETOSTEARYL SULFATE7ZBS06BH4BCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 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
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
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM CETOSTEARYL SULFATESODIUM CETOSTEARYL SULFATE7ZBS06BH4BCREAM / TOPICAL1 %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
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact 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
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
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact 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
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
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM CETOSTEARYL SULFATESODIUM CETOSTEARYL SULFATE7ZBS06BH4BCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
4 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 ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
ndc (package): 69740-312-00
ndc (package): 69740-311-00
ndc (product): 69740-311
ndc (product): 69740-312
ndc11 (package): 69740031200
ndc11 (package): 69740031100
spl id: 1ab291a4-b8b3-e4f6-e063-6394a90a3d30
spl set id: b077aa64-49a3-42ee-abb3-88f833635b93

Reported adverse events (FAERS/openFDA)#

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