159 Remedy Specialized Silicone Cream

Manufacturer
Medline Industries, LP
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-29 01:03:58

Label at a glance#

ProductMedline
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly, cleans the diaper area and allow to dry apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 12.5% w/v

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out 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 for 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

  • change wet and soiled diapers promptly, cleans the diaper area and allow to dry
  • apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, C12-13 pareth-23, C12-13 pareth-3, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer emulsion, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, jojoba esters, lauryl PEG-10 tris (trimethylsiloxy) silylethyl dimethicone, manuka honey, olea europaea (olive) oil, PEG/PPG-18/18 dimethicone, phenoxyethanol, phospholipids, phytonadione, propanediol, purified water, sodium chloride, stearic acid, tocopheryl acetate, yeast ferment extract, zea mays (corn) oil.

Manufacturing Information

SPL UNCLASSIFIED SECTION

©2022 Medline Remedy and Meldine

are registered trademearks of Medline

Industries, LP. Made in USA of domestic and

imported materials. Manufactured for Medline

Industries, LP, Three Lakes Drive, Northfield, IL

60093 USA. 1-800-MEDLINE (633-5463)

Change to Uses section

RECENT MAJOR CHANGES SECTION

Added word to Uses section that was inadvertently missed, but present on current labeling.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130888277703783GTIN-13: 0888277703783
EAN-13: 0888277703783
GTIN-12: 888277703783
UPC-A: 888277703783
GTIN storage (14 digits): 00888277703783
MSC092564_V3 RK23PUA_Package Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-15953329-159-13, 53329-159-04, 53329-159-77, 53329-159-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-05-01full-release2026-06-01 00:12:25

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
18582056-72e0-f103-e063-6394a90a1de2ddab5235-1188-3866-e053-2a95a90a7a312024-05-01WarningsExact identifier
spl set id: ddab5235-1188-3866-e053-2a95a90a7a31

Reported adverse events (FAERS/openFDA)#

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