FDA.reportPublic FDA data

Secura Extra Protective Cream

Manufacturer
Smith & Nephew Medical Ltd | ENCUBE ETHICALS PVT LTD
Effective date
2025-04-17
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 00:59:17

Label at a glance#

ProductSecura Extra Protective
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

skin protectant helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness Amendment from reference to 'dermatitis' to 'rash' Apr 2025

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 change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Storage and handling

Store at controlled room temperature 59 o F-86 o F (15 o C-30 o C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 30.6%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

USES

INDICATIONS & USAGE SECTION

  • skin protectant
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness

Update in line with OTC Monograph

RECENT MAJOR CHANGES SECTION

Amendment from reference to 'dermatitis' to 'rash'

Apr 2025

WARNINGS

WARNINGS SECTION

  • For external use only
  • Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clears up and occur again within a few days
  • When using this product do not get into eyes
  • Not to be applied over deep or puncture wounds, infections, or lacerations
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Certer immediately

OTC - STOP USE SECTION

  • If condition worsensor does not improve within 7 days, contact a doctor

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 change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59 oF-86 oF (15 oC-30 oC)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, methyl glucose dioleate, methylparaben, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (92g)

Item #59432400

NDC 69740-324-00

Extra Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-associated dermatitis
  • For use on denuded skin associated with exposure to feces or urine
  • Adheres to macerated skin
  • Pediatric tested
  • CHG compatible

Smith & Nephew

Secura ◊

Extra Protective Cream

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. and Tm. Off.

69740-324-0069740-324-00

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g)

Item #59432500

NDC69740-325-00

Extra Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-associated dermatitis
  • For use on denuded skin associated with exposure to feces or urine
  • Adheres to macerated skin
  • Pediatric tested
  • CHG compatible


Smith & Nephew

Secura◊

Extra Protective Cream

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. and Tm. Off.

219grams-secura-label219grams-secura-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477180zinc oxide 30.6 % Topical CreamPSN17
477180zinc oxide 306 MG/ML Topical CreamSCD17
477180zinc oxide 30.6 % Topical CreamSY17
477180ZNO 306 MG/ML Topical CreamSY17

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
69740-324-002024-03-12C16284748780-11030e365-2edc-111a-e063-dadaa90a10e2Secura Extra Protective Cream
69740-325-002024-03-12C16284748780-11030e365-2edc-111a-e063-dadaa90a10e2Secura Extra Protective Cream
69740-324-002024-01-30C16284748780-11030e365-2edc-111a-e063-dadaa90a10e2Secura Extra Protective Cream
69740-325-002024-01-30C16284748780-11030e365-2edc-111a-e063-dadaa90a10e2Secura Extra Protective Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-324-00Secura Extra Protective92 g in 1 TUBECREAM9217
69740-325-00Secura Extra Protective Cream219 g in 1 TUBECREAM21917

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-324SECURA EXTRA PROTECTIVE (ZINC OXIDE) CREAM SECURA EXTRA PROTECTIVE CREAM (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]17Current NDC, Legacy NDC, 1 package rows20250418_499a1944-1682-4798-9058-3748a5eaa420.zip
69740-325SECURA EXTRA PROTECTIVE (ZINC OXIDE) CREAM SECURA EXTRA PROTECTIVE CREAM (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]17Current NDC, Legacy NDC, 1 package rows20250418_499a1944-1682-4798-9058-3748a5eaa420.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-324-00GM - Gram69740-324caec3a42-2d5e-4396-8c9c-13b3b80b5b5712025-01-14

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-32469740-324-00
69740-32569740-325-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE GUMK679OBS311IACT
BENZETHONIUM CHLORIDEPH41D05744IACT
BUTYLPARABEN3QPI1U3FV8IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
XANTHAN GUMTTV12P4NEEIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIM
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
CELLULOSE GUMK679OBS311IACT
BENZETHONIUM CHLORIDEPH41D05744IACT
BUTYLPARABEN3QPI1U3FV8IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
KARAYA GUM73W9IQY50QIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIB
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
ndc (package): 69740-325-00
ndc (package): 69740-324-00
ndc (product): 69740-325
ndc (product): 69740-324
ndc11 (package): 69740032400
ndc11 (package): 69740032500
spl id: 32f9f454-2e5a-01df-e063-6294a90af651
spl set id: 499a1944-1682-4798-9058-3748a5eaa420

Reported adverse events (FAERS/openFDA)#

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