FDA.reportPublic FDA data

3M Cavilon Durable Barrier

Manufacturer
Solventum US LLC
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:26:18

Label at a glance#

Product3M Cavilon Durable Barrier
Active ingredientDimethicone
Label structure9 sections

Indications and uses

Protection of at-risk skin from damage associated with incontinence and related symptoms.

Dosage and administration

Gently cleanse skin as required. Apply 3M™ Cavilon™ Durable Barrier Cream sparingly to cover entire affected area. Repeat as necessary. If the feel is oily, too much has been applied. Active ingredient  (w/w) : Dimethicone 1.3%

Storage and handling

Store between 15°C to 30°C (59°F to 86°F).  Please see outer label/carton for complete directions for use and warnings/precautions.

Label contents#

Full prescribing information#

Uses:

INDICATIONS & USAGE SECTION

Protection of at-risk skin from damage associated with incontinence and related symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

Gently cleanse skin as required. Apply 3M™ Cavilon™ Durable Barrier Cream sparingly to cover entire affected area. Repeat as necessary. If the feel is oily, too much has been applied.

Active ingredient (w/w) : Dimethicone 1.3%

Storage Conditions:

STORAGE AND HANDLING SECTION

Store between 15°C to 30°C (59°F to 86°F). Please see outer label/carton for complete directions for use and warnings/precautions.

Usages :

INDICATIONS & USAGE SECTION

Protection de la peau à risque contre les lésions associées à l'incontinence et les symptômes connexes.

Mode d'emploi :

DOSAGE & ADMINISTRATION SECTION

Nettoyer délicatement la peau selon les besoins. Appliquer la Crème protectrice durable CavilonMC 3MMC avec modération afin de couvrir l'ensemble de la zone atteinte. Répéter au besoin. Si la peau est grasse au toucher, c'est qu'une trop grande quantité de crème a été appliquée.

Ingrédient actif (p/p) : Diméthicone à 1,3 %

Conditions d'entreposage :

STORAGE AND HANDLING SECTION

Entreposer à une température de 15 °C à 30 °C (59 °F à 86 °F). Consulter l'étiquette ou le carton extérieur pour obtenir des renseignements complets sur les usages, le mode d'emploi, les avertissements ainsi que les précautions.

3M CANADA COMPANY

LA COMPAGNIE 3M CANADA

300 TARTAN DRIVE, LONDON, ON N5V 4M9

QUESTIONS? 1-800-364-3577

www.3M.ca

3M and Cavilon are trademarks of 3M. Used under license in Canada. 3M et Cavilon sont des marques de commerce de 3M, utilisées sous licence au Canada. © 2021, 3M. All rights reserved. Tous droits réservés. 34-8727-0667-5

Principal Display Panel – CA Tube Label (28g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT

3M

DIN 02455838

Cavilon™/MC

Durable Barrier Cream
Crème protectrice durable

Dimethicone Cream NF Skin Protectant 1.3% (w/w)

Protecteur cutané à la diméthicone NF 1,3 %(p/p)

Protects from incontinence

  • Resists wash-off •Concentrated
  • Allows tape to stick
  • Moisturizes and conditions dry skin
  • Fragrance free •Parabens free

Protège contre les effets de l'incontinence

  • Résiste au rinçage • Concentrée
  • Permet au ruban adhésif d'adhérer
  • Hydrate et revitalise la peau sèche
  • Non parfumée • Sans parabènes

REF

3991C          28g

Figure
Figure

Principal Display Panel – EU Tube Label (28g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT

3M

CavilonTM

En Durable Barrier Cream

REF

3391G

Net Weight 28g -1oz.

Figure
Figure

Principal Display Panel – UKCA Tube Label (28g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT

3M

CavilonTM

Durable Barrier Cream

REF

3391G

Net Weight 28g -1oz.

Figure
Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309916dimethicone 1.3 % Topical CreamPSN7
309916dimethicone 13 MG/ML Topical CreamSCD7
309916dimethicone 0.65 GM per 50 ML Topical CreamSY7
309916dimethicone 1.3 % Topical CreamSY7
309916dimethicone 1.95 GM per 150 ML Topical CreamSY7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00707387792268GTIN-14: 00707387792268
GTIN-12: 707387792268
UPC-A: 707387792268
EAN-13: 0707387792268
GTIN storage (14 digits): 00707387792268		3mx0o-0006-03.jpg
Data codeData Matrix348726155873mx0o-0006-02.jpg
Data codeQR Code7073877923293mx0o-0006-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-030-043M Cavilon Durable Barrier0.0000273 L in 1 PACKETCREAM0.00002737
17518-030-053M Cavilon Durable Barrier0.000383 L in 1 TUBECREAM0.0003837
17518-030-063M Cavilon Durable Barrier0.00126 L in 1 TUBECREAM0.001267

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-030-02GM - Gram17518-030a095b4c7-30e9-4761-b167-23a355766d4112024-04-05
17518-030-03GM - Gram17518-030b3779a1e-8e2c-49c1-83fb-40e52c200b1012018-05-09

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17518-03017518-030-06, 17518-030-05, 17518-030-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Benzoic Acid8SKN0B0MIMIACT
Coconut OilQ9L0O73W7LIACT
Dehydroacetic Acid2KAG279R6RIACT
Diisooctyl Adipate2TLQ9O0CWBIACT
GlycerinPDC6A3C0OXIACT
Isopropyl Palmitate8CRQ2TH63MIACT
Magnesium Sulfate HeptahydrateSK47B8698TIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
PhenoxyethanolHIE492ZZ3TIACT
PPG-15 Stearyl Ether1II18XLS1LIACT
Water059QF0KO0RIACT

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
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
ndc (product): 17518-030
52770f14-60c3-4f62-8b4a-08a5246499a042b95b12-d4e0-4069-bf60-56bbdb4afc1f2025-12-09Exact identifier
spl id: 52770f14-60c3-4f62-8b4a-08a5246499a0
spl set id: 42b95b12-d4e0-4069-bf60-56bbdb4afc1f

Reported adverse events (FAERS/openFDA)#

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