FDA.reportPublic FDA data

DERMASIL ADVANCED

Manufacturer
Kingkey MBC Life Technology Group Co., Ltd.
Effective date
2023-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:38

Label at a glance#

ProductDERMASIL ADVANCED
Active ingredientDIMETHICONE
Label structure7 sections

Dosage and administration

Apply to Hands and Body every day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.
Do not get into eyes.
Stop use and ask a doctor if: Condition worsens, Symptoms last more than 7 days or clear up and occur again within a few days.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to Hands and Body every day.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN , BORAGO OFFICINALIS SEED OIL, CHOLESTEROL, ASCORBYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ETHYLENE BRASSYLATE, SANTALUM ALBUM (SANDALWOOD) OIL, ROSA DAMASCENA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Advanced Treatment

CREAMY LOTION

8 FL OZ (236 ml)image descriptionimage description

NDC: 73928-101-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
880878Dermasil 1 % Topical LotionPSN1
199680dimethicone 1 % Topical LotionPSN1
880878dimethicone 10 MG/ML Topical Lotion [Dermasil]SBD1
199680dimethicone 10 MG/ML Topical LotionSCD1
880878Dermasil 1 % Topical LotionSY1
880878Dermasil 10 MG/ML Topical LotionSY1
199680dimethicone 1 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73928-101-012025-01-30C16284748780-12cef2736-9446-d83d-e063-dadaa90ab31fda09e418-e9b1-42d5-8685-18cd601cc8f6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73928-101-01DERMASIL ADVANCED236 mL in 1 TUBElotion2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73928-101DERMASIL ADVANCED (DIMETHICONE) LOTION [KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD.]11 package rows20230717_da09e418-e9b1-42d5-8685-18cd601cc8f6.zip

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
73928-10173928-101-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
CETYL ALCOHOL936JST6JCNIACT
CETYL OLEATE78K2L26L8NIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
SUNFLOWER OIL3W1JG795YIIACT
EDETATE DISODIUM7FLD91C86KIACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BORAGE OILF8XAG1755SIACT
CHOLESTEROL97C5T2UQ7JIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALMOND OIL66YXD4DKO9IACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
SANDALWOOD OILX7X01WMQ5FIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
VANILLAQ74T35078HIACT
NIACINAMIDE25X51I8RD4IACT
INOSITOL4L6452S749IACT

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
174e201c-8f17-4a04-8a3e-22133282ffc9da09e418-e9b1-42d5-8685-18cd601cc8f62023-07-17WarningsExact identifier
spl id: 174e201c-8f17-4a04-8a3e-22133282ffc9
spl set id: da09e418-e9b1-42d5-8685-18cd601cc8f6

Reported adverse events (FAERS/openFDA)#

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