FDA.reportPublic FDA data

Sween 24

Manufacturer
Coloplast Corp | Medline Industries, LP
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:51:53

Label at a glance#

ProductSween 24
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin and lips.

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone, 6%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped or cracked skin and lips.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop using this product if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

behentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll free 1-800-533-0464

SPL UNCLASSIFIED SECTION

Manufactured by: Coloplast A/S, Holtedam 1,
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp, 1601 W River Rd N,
Minneapolis, MN 55411 U.S.A.

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11701-063-73

Sween® 24

Moisturizer
Once a Day
Moisturizing
Body Cream

For Normal to Dry,
Flaky, Itchy Skin

Product #7091

Coloplast

NET WT. 2 OZ. (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Label
PRINCIPAL DISPLAY PANEL - 57 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577215dimethicone 6 % Topical CreamPSN9
577215dimethicone 60 MG/ML Topical CreamSCD9
577215dimethicone 6 % Topical CreamSY9

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
11701-063-702023-12-21C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-712023-12-21C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-722023-12-21C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-732023-12-21C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-702023-01-30C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-712023-01-30C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-722023-01-30C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24
11701-063-732023-01-30C16284748780-1f386c649-9c31-0266-e053-dadaa90a7c1aSween ® 24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-063-70Sween 24256 g in 1 TUBECREAM2569
11701-063-71Sween 24142 g in 1 TUBECREAM1429
11701-063-72Sween 244 g in 1 PACKETCREAM49
11701-063-73Sween 2457 g in 1 TUBECREAM579

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-063-13GM - Gram11701-0631255ab68-642d-47d0-b37d-faf8a31df53012013-02-11
11701-063-14GM - Gram11701-063d8df7f01-978a-4db5-ad98-e48d3f30cc7912013-02-11
11701-063-22GM - Gram11701-063a6d5fd11-dd85-4d50-83b8-ef79856575ba12015-10-02
11701-063-23GM - Gram11701-063540c564e-0137-42ac-85b8-39f8a505e1b012012-07-24
11701-063-71GM - Gram11701-0632e0846d0-b6f8-4bb2-8c2e-fad7bc527b5012026-04-20
11701-063-73GM - Gram11701-06369e6301a-2f54-4ab7-8134-303ef092a8e712024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O5
DIMETHICONEACTIVE MOIETY92RU3N3Y1O5
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C615
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S5
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933095
GLYCERININACTIVE INGREDIENTPDC6A3C0OX5
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M5
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AM5
WATERINACTIVE INGREDIENT059QF0KO0R5

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
11701-06311701-063-71, 11701-063-70, 11701-063-73, 11701-063-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMIACT
WATER059QF0KO0RIACT

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 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
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
ndc (package): 11701-063-70
ndc (package): 11701-063-72
ndc (package): 11701-063-73
ndc (package): 11701-063-71
ndc (product): 11701-063
ndc11 (package): 11701006372
ndc11 (package): 11701006373
ndc11 (package): 11701006371
ndc11 (package): 11701006370
spl id: 8435a838-1f5b-4d98-95eb-2f1b684a0e74
spl set id: a623c8d7-8db0-410a-9980-02ac02f7b6ea

Reported adverse events (FAERS/openFDA)#

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