FDA.reportPublic FDA data

154 Remedy Specialized Skin Cream (scented)

Manufacturer
Medline Industries, LP
Effective date
2026-08-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-04 01:01:22

Label at a glance#

ProductMedline
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

helps prevent and temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

apply to full body as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.5% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects and helps relieve chapped or cracked skin
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Do not use

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

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply to full body as needed

Other information

OTHER SAFETY INFORMATION

  • protect from freezing
  • avoid excessive heat
  • not made with Natural Rubber Latex

Inactive ingredients

INACTIVE INGREDIENT SECTION


acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, glycine, niacinamide, olea europaea (olive) fruit extract, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCL, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

©2025 Medline and Medline Remedy

are registered trademarks of

Medline Industries, LP.

Made in USA of foreign and domestic materials.

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MSC0924402

Directions update

RECENT MAJOR CHANGES SECTION

Updating directions to align with M016

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-15453329-154-13, 53329-154-04, 53329-154-23, 53329-154-84, 53329-154-77, 53329-154-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
NIACINAMIDE25X51I8RD4IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CORN OIL8470G57WFMIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
HYDRATED SILICAY6O7T4G8P9IACT
CANOLA OIL331KBJ17RKIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-100 STEARATEYD01N1999RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ACETYLCYSTEINEWYQ7N0BPYCIACT
TAURINE1EQV5MLY3DIACT
PROLINE9DLQ4CIU6VIACT
ARGININE94ZLA3W45FIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCINETE7660XO1CIACT
PEG-8B697894SGQIACT
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OILAKN3KSD11BIACT
CITRUS PARADISI (GRAPEFRUIT) PEEL OILYR377U58W9IACT
CITRUS RETICULATA FRUIT OIL25P9H3QU5EIACT
OLEA EUROPAEA (OLIVE) FRUIT2M6QWV94OCIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
OLEA EUROPAEA (OLIVE) LEAFMJ95C3OH47IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-10-28full-release2026-06-01 01:41:06
12023-12-28full-release2026-06-01 00:05:52

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
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
ndc (package): 53329-154-77
ndc (package): 53329-154-96
ndc (package): 53329-154-04
ndc (package): 53329-154-84
ndc (package): 53329-154-13
ndc (package): 53329-154-23
ndc (product): 53329-154
ndc11 (package): 53329015477
ndc11 (package): 53329015496
ndc11 (package): 53329015484
ndc11 (package): 53329015423
ndc11 (package): 53329015404
ndc11 (package): 53329015413
spl id: 59cc632c-fe5e-38fd-e063-6394a90a2261
spl set id: 0d94fd18-a120-e171-e063-6394a90ae9c0

Reported adverse events (FAERS/openFDA)#

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