FDA.reportPublic FDA data

152 Remedy Intensive Skin Therapy Skin Repair Cream, Orange Vanilla Scent

Manufacturer
Medline Industries, LP
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:02:47

Label at a glance#

ProductMedline Remedy Phytoplex Skin Repair
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather.

Dosage and administration

apply as needed

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather.

Warnings

WARNINGS SECTION

For External Use Only.

Do not use

OTC - DO NOT USE SECTION

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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

  • apply as needed

Other information

STORAGE AND HANDLING SECTION

  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

algae extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, citrus paradisi (grapefruit) peel oil, citrus reticulata (tangerine) peel oil, citrus sinensis (orange) peel oil, cetyl alcohol, cocos nucifera (coconut oil),
7-dehydrocholesterol, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, isopropyl myristate, jojoba esters, manuka honey, methyldihydrojasmonate, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, purified water, propanediol, stearic acid, tocopherol acetate, vanilla planifolia extract, yeast ferment extract, zea mays (corn) oil.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Phytoplex, Medline Remedy, and Medline are registered trademarks of Medline Industries Inc. Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of domestic and imported materials.

www.medline.com 1-800-MEDLINE

RK20BLB

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-152MEDLINE REMEDY PHYTOPLEX SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]10Legacy NDC20240514_629d0aad-bde9-e07a-e053-2a91aa0a05c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-152-04GM - Gram53329-15239008f22-6a04-4e7c-95fb-7bc29f80f0f312018-04-19

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-15253329-152-14, 53329-152-44, 53329-152-64, 53329-152-04, 53329-152-17, 53329-152-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELIDIELLA ACEROSAT91K54D6M1IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
HONEYY9H1V576FHIACT
PHYTONADIONEA034SE7857IACT
ORANGE OILAKN3KSD11BIACT
CLOVEK48IKT5321IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHOLECALCIFEROL1C6V77QF41IACT
MANDARIN OILNJO720F72RIACT
COCONUT OILQ9L0O73W7LIACT
GRAPEFRUIT OILYR377U58W9IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPANEDIOL5965N8W85TIACT
GLYCOL DISTEARATE13W7MDN21WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLDECANOL151Z7P1317IACT
.BETA.-BISABOLOLLP618AV2EAIACT
OLIVE OIL6UYK2W1W1EIACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERINPDC6A3C0OXIACT
RAPESEED STEROLB46B6DD20UIACT
STEARIC ACID4ELV7Z65APIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
VANILLINCHI530446XIACT
WATER059QF0KO0RIACT
CORN OIL8470G57WFMIACT
DIMETHICONE92RU3N3Y1OACTIB

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
1858a59b-57fd-710f-e063-6294a90a460c629d0aad-bde9-e07a-e053-2a91aa0a05c82024-05-13WarningsExact identifier
spl id: 1858a59b-57fd-710f-e063-6294a90a460c
spl set id: 629d0aad-bde9-e07a-e053-2a91aa0a05c8

Reported adverse events (FAERS/openFDA)#

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