Medline

Manufacturer
Medline Industries, LP
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:39

Label at a glance#

ProductMedline
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash. Protects minor skin irritation due to diaper rash and helps protect from wetness

Dosage and administration

open package as designated remove cloths and throughly cleanse apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3.2 w/v

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin
  • helps treat and prevent diaper rash. Protects minor skin irritation due to diaper rash and helps protect from wetness

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • open package as designated
  • remove cloths and throughly cleanse
  • apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • protect from freezing, avoid excessive heat
  • keep lid tightly sealed
  • not made with natural rubber latex
  • cloth: made of 98% cellulosic fibers

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzalkonium chloride, citric acid, cocamidopropyl pg-dimonium chloride phosphate, disodium edta, linoleamidopropyl pg-dimonium chloride phosphate, polysorbate 20, simethicone, sodium benzoate, water (aqua)

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured by:
Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF:MSC263011

V1 RC23MSC

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RC23MSCLabel V1 RC23MSC

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-185MEDLINE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]2Unmatched20240120_f277f43b-5453-c790-e053-2995a90aab7d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-18553329-185-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4081bc27-6e6a-2cd1-e063-6294a90aece0f277f43b-5453-c790-e053-2995a90aab7d2025-10-06WarningsExact identifier
spl set id: f277f43b-5453-c790-e053-2995a90aab7d

Reported adverse events (FAERS/openFDA)#

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