Skin Repair Complex

Manufacturer
PureTek Corporation
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:22:26

Label at a glance#

ProductSkin Repair Complex
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

■ temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

■ apply cream liberally as needed

Storage and handling

■ protect from freezing ■ avoid excessive heat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Do not use on

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ apply cream liberally as needed

Other information

STORAGE AND HANDLING SECTION

■ protect from freezing ■ avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex ® [consisting of: bisabolol, calcium pantothenate (vitamin B 5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3), pyridoxine HCl (vitamin B 6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

DermacinRx ® Skin Repair Complex (4 oz tube label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin Repair Complex 4oz tube labelSkin Repair Complex 4oz tube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259090dimethicone 5 % Topical CreamPSN5
259090dimethicone 50 MG/ML Topical CreamSCD5
259090dimethicone 5 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-333-08Skin Repair Complex118 mL in 1 TUBECREAM1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-333SKIN REPAIR COMPLEX (DIMETHICONE) CREAM [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_1c3059c5-5f7e-264e-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3D1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARTHAMUS TINCTORIUS SEED OLEOSOMESINACTIVE INGREDIENT9S60Q723091
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OK1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GINGERINACTIVE INGREDIENTC5529G5JPQ1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8R1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MS1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BV1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-33359088-333-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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 2 · 68 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
4 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
30 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
GINGERGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
4 equally ranked IID candidates
GINGERGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
30 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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermacinRx ZRM PakLIDOCAINE, DIMETHICONEPureTek Corporation57c4672d-37b1-4af3-a9fc-d8390016338d2025-01-14Warnings, Adverse reactionsExact identifier
ndc (package): 59088-333-08
ndc11 (package): 59088033308
DermacinRx Surgical ComboPakCHLORHEXIDINE GLUCONATE SURGICAL COMBO KITPureTek Corporation7aff8c66-e758-438a-872d-804a35bb372a2024-12-13WarningsExact identifier
ndc (package): 59088-333-08
ndc11 (package): 59088033308
DermacinRx ClorhexacinMUPIROCIN OINTMENTPureTek Corporation3c8cb9a6-58e5-4e8d-bfdc-1432a1bde6f92024-12-13Warnings, Adverse reactionsExact identifier
ndc (package): 59088-333-08
ndc11 (package): 59088033308
FluoparFLUOCINONIDE, DIMETHICONEPureTek Corporation9ff7fa78-0fca-976f-e053-2995a90a46412024-12-13Warnings, Adverse reactionsExact identifier
ndc (package): 59088-333-08
ndc11 (package): 59088033308
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
ndc (package): 59088-333-08
ndc (product): 59088-333
ndc11 (package): 59088033308
spl id: 2373d428-b3f6-2678-e063-6394a90a6ecd
spl set id: 1c3059c5-5f7e-264e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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