FDA.reportPublic FDA data

Secura Dimethicone Protectant

Manufacturer
Smith & Nephew Medical Ltd | Swiss-American CDMO, LLC
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:43:58

Label at a glance#

ProductSecura Dimethicone Protectant
Active ingredientDIMETHICONE
Label structure12 sections

Indications and uses

Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness Temporarily protects and helps relieve chapped or cracked skin and lips

Dosage and administration

Apply as needed 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 INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

USES

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
  • Temporarily protects and helps relieve chapped or cracked skin and lips

WARNINGS

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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

  • Apply as needed
  • 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, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g)

Item #59435000

NDC 69740-322-01

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura ◊

Dimethicone Protectant

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

Certain marks reg'd in U.S. Pat and Tm Off.

dimeth-3-5gdimeth-3-5g

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (114 g)

Item #59432200

NDC 69740-322-00

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura ◊

Dimethicone Protectant

Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England.

www.smith-nephew.com

Trademark of Smith & Nephew.

Certain marks reg'd U.S. Pat and Tm. Off.

imadimeth-114gimadimeth-114g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259090dimethicone 5 % Topical CreamPSN10
259090dimethicone 50 MG/ML Topical CreamSCD10
259090dimethicone 5 % Topical CreamSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-322-002024-08-20C16284748780-1f386c649-c42b-0266-e053-dadaa90a7c1aSecura Dimethicone Protectant
69740-322-012024-08-20C16284748780-1f386c649-c42b-0266-e053-dadaa90a7c1aSecura Dimethicone Protectant
69740-322-002023-01-30C16284748780-1f386c649-c42b-0266-e053-dadaa90a7c1aSecura Dimethicone Protectant
69740-322-012023-01-30C16284748780-1f386c649-c42b-0266-e053-dadaa90a7c1aSecura Dimethicone Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-322-00Secura Dimethicone Protectant114 g in 1 TUBECREAM11410
69740-322-01Secura Dimethicone Protectant3.5 g in 1 PACKETCREAM3.510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-322SECURA DIMETHICONE PROTECTANT (DIMETHICONE) CREAM [SMITH & NEPHEW MEDICAL LTD]10Current NDC, Legacy NDC, 2 package rows20241218_83f92ac9-4114-4192-926d-be2854a84106.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-322-00GM - Gram69740-3220d4d9c45-cef4-4169-9c68-d771aa2facc312023-04-07

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-32269740-322-01, 69740-322-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXYL LAURATE4CG9F9W01QIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OACTIB
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT

Source Document#

Source XML · Source PDF

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 Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
ndc (package): 69740-322-01
ndc (package): 69740-322-00
ndc (product): 69740-322
ndc11 (package): 69740032201
ndc11 (package): 69740032200
spl id: 29664526-07fd-f58e-e063-6294a90adde2
spl set id: 83f92ac9-4114-4192-926d-be2854a84106

Reported adverse events (FAERS/openFDA)#

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