FDA.reportPublic FDA data

142 Remedy® with Olivamine® Dimethicone Moisture Barrier Cream

Manufacturer
Medline Industries, LP
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 22:33:57

Label at a glance#

ProductRemedy Dimethicone Moisture Barrier Unscented
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

protects from minor skin irritation associated with diaper rash caused from wetness, urine and/or stool temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

cleanse skin apply cream liberally until entire area is covered apply as needed 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

  • protects from minor skin irritation associated with diaper rash caused from wetness, urine and/or stool
  • temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For External Use Only.

Do not use

OTC - DO NOT USE SECTION

on deep or puncture wounds, on animal bites, or 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

  • cleanse skin
  • apply cream liberally until entire area is covered
  • apply as needed
  • protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, cetyl alcohol, cholecalciferol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate se, glycine, helianthus annuus seed oil, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea leaf extract , peg-8, peg-100 stearate, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, rosa canina fruit oil, stearic acid, stearyl alcohol, tetrasodium edta, tocopherol, triethanolamine, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for/Fabriqué pour: Medline Industries, Inc.,

Three Lakes Drive, Northfield, IL 60093 USA.

Imported by/Importé par Medline Canada, Oakville, ON L6L 6R2

www.medline.com

1-800-MEDLINE

REF: MSC094851UNSC

RJ18WAR

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O4
DIMETHICONEACTIVE MOIETY92RU3N3Y1O4
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ14
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYC4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R4
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF414
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
CORN OILINACTIVE INGREDIENT8470G57WFM4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW44
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
GLYCINEINACTIVE INGREDIENTTE7660XO1C4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD44
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ4
PROLINEINACTIVE INGREDIENT9DLQ4CIU6V4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BV4
ROSA CANINA FRUITINACTIVE INGREDIENT3TNW8D08V34
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y4
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI4
TAURINEINACTIVE INGREDIENT1EQV5MLY3D4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-14253329-142-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLEA EUROPAEA LEAFMJ95C3OH47IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROXYTYROSOLQEU0NE4O90IACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCINETE7660XO1CIACT
SUNFLOWER OIL3W1JG795YIIACT
PROLINE9DLQ4CIU6VIACT
TAURINE1EQV5MLY3DIACT
METHYLPARABENA2I8C7HI9TIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ACETYLCYSTEINEWYQ7N0BPYCIACT
NIACINAMIDE25X51I8RD4IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB
EDETATE SODIUMMP1J8420LUIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 624 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER, FOR SOLUTION / ORAL0.09 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates

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
ebe27b4a-ffa7-7d1f-e053-2995a90a4bf6c5c55cad-e7af-424d-b939-00c8dab157de2022-10-25WarningsExact identifier
spl set id: c5c55cad-e7af-424d-b939-00c8dab157de

Reported adverse events (FAERS/openFDA)#

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