FDA.reportPublic FDA data

Dermasil

Manufacturer
Rise International Group LLC | Kingkey Daily Chemical Co LTD
Effective date
2014-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:37:35

Label at a glance#

ProductDermasil
Active ingredientDIMETHICONE
Label structure4 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dermasil® Labs has developed Dermasil® OTC pharmaceuticals skincare, a powerful dry skin treatment and skin protectant.
This lotion contains four systems to control and provide long-lasting relief from severe dry skin:

  • Occlusives to block moisture loss from the skin's surface
  • Humectant to bind water in the skin's outermost layers
  • Skin Lipids to enhance the skin's natural ability to retain moisture
  • EFA's an important component of the skin's moisture barrier

Indications:

SPL UNCLASSIFIED SECTION

Suitable for severe dry skin, and control of symptoms such as chapping, cracking, flaking, roughness, redness, soreness, and the itching associated with dry skin.

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Dimethicone 1 %

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

  • For external use only.
  • Do not get into eyes.
OTC - STOP USE SECTION
  • 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
  • Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, PEG-40 Stearate, Cetyl Alcohol, Phenoxyethanol, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Sodium Hydroxide, Acetylated Lanolin Alcohol, Carbomer, Disodium EDTA, Geranium Maculatum Oil, 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

FigureFigure

Cruelty-Free. No Animal Testing.

Please Recycle This Bottle.

www.riseintlgroup.com

RISE INTERNATIONAL GROUP LLC

Lodi, NJ 07644. Made in China

© RISE INTERNATIONAL GROUP LLC

Principal Display Panel - Tube Label Dermasil 10oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25% MORE
Dermasil ®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil ®
Dry Skin Treatment
ORIGINAL LOTION
10 FL OZ (296 ml)

Principal Display Panel - 10 FL.0Z (296 ml)
Principal Display Panel - 10 FL.0Z (296 ml)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67143-2101-42024-11-18C16284748780-19855e2a2-4ce0-60a7-e053-dbdaa90a05bdDermasil ® Labs
67143-2101-62024-11-18C16284748780-19855e2a2-4ce0-60a7-e053-dbdaa90a05bdDermasil ® Labs
67143-2101-42019-11-27C16284748780-19855e2a2-4ce0-60a7-e053-dbdaa90a05bdDermasil ® Labs
67143-2101-62019-11-27C16284748780-19855e2a2-4ce0-60a7-e053-dbdaa90a05bdDermasil ® Labs

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O5
DIMETHICONEACTIVE MOIETY92RU3N3Y1O5
ALMONDINACTIVE INGREDIENT3Z252A2K9G5
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N5
BORAGEINACTIVE INGREDIENTPB618V0K2W5
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN5
CETYLPYRIDINIUM ACETATEINACTIVE INGREDIENT6W29RZ7YU25
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K5
GERANIUM MACULATUM ROOTINACTIVE INGREDIENT93IXI5B6OJ5
GLYCERININACTIVE INGREDIENTPDC6A3C0OX5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE45
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E5
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB5
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM625
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC5
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI5
VANILLAINACTIVE INGREDIENTQ74T35078H5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67143-210167143-2101-4, 67143-2101-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
SUNFLOWER OIL3W1JG795YIIACT
CETYLPYRIDINIUM ACETATE6W29RZ7YU2IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE DISODIUM7FLD91C86KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BORAGEPB618V0K2WIACT
CHOLESTEROL97C5T2UQ7JIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALMOND3Z252A2K9GIACT
VANILLAQ74T35078HIACT
GERANIUM MACULATUM ROOT93IXI5B6OJIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 9 · 498 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE / ORAL60 mgExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JCREAM / VAGINAL0.3 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDROPS / OPHTHALMICNAExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 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
c5626305-e634-4b97-9d47-fc86f93d955b51eb9d32-52b5-4cea-aa6e-c1770437c4ac2024-11-15WarningsExact identifier
spl set id: 51eb9d32-52b5-4cea-aa6e-c1770437c4ac

Reported adverse events (FAERS/openFDA)#

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