Sween 24 Cream
FDA Label NDC 11701-063

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Sween 24 (NDC 11701-063). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop using this product if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

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.

Otc - Do Not Use

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.

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (57 g Tube Label)

Principal Display Panel (57 g Tube Label)

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