SWEEN 24- dimethicone cream

Sween 24 by

Drug Labeling and Warnings

Sween 24 by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dimethicone, 6%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only.

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• Do not get into eyes

Stop using this product if

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

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

• apply as needed

Inactive ingredients

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

Questions or comments?

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

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)

INGREDIENTS AND APPEARANCE

SWEEN 24 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-063-71	142 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-063-70	256 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
3	NDC: 11701-063-73	57 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
4	NDC: 11701-063-72	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-063)