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Sween 24

Dosage form: cream
Ingredients: DIMETHICONE 60mg in 1g
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-063

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Sween® 24

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

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)

SWEEN 24 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-063
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BEHENTRIMONIUM METHOSULFATE 
CETOSTEARYL ALCOHOL 
ETHYLHEXYL PALMITATE 
GLYCERIN 
ISOPROPYL PALMITATE 
PEG-150 PENTAERYTHRITYL TETRASTEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:11701-063-71142 g in 1 TUBE
2NDC:11701-063-70256 g in 1 TUBE
3NDC:11701-063-7357 g in 1 TUBE
4NDC:11701-063-724 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-063)

Revised: 07/2015
 
Coloplast Manufacturing US, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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