FDA.reportPublic FDA data

Dimopair

Manufacturer
PureTek Corporation
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:36

Label at a glance#

ProductDimopair
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

■ apply cream liberally as needed

Storage and handling

■ protect from freezing ■ avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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

■ helps prevent and protect from the drying effects of wind and cold weather

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

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aleuritis Moluccanus (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, GenRx Complex® [consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract], Dimethicone Crosspolymer, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Sodium Hydroxide, Stearic Acid.

Dimopair™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259090dimethicone 5 % Topical CreamPSN3
259090dimethicone 50 MG/ML Topical CreamSCD3
259090dimethicone 5 % Topical CreamSY3

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
59088-623-08Dimopair118 mL in 1 TUBECREAM1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-623DIMOPAIR (DIMETHICONE) CREAM [PURETEK CORPORATION]3Current NDC, 1 package rows20241004_dc16af56-b97d-c17f-e053-2995a90a55a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-623-08ML - Milliliter59088-623384ed24d-2cb3-43a0-9a75-36c8420ad75112023-05-05

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-62359088-623-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERRSA9I561OKIACT
KUKUI NUT OILTP11QR7B8RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LEVOMENOL24WE03BX2TIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
MALTODEXTRIN7CVR7L4A2DIACT
NIACINAMIDE25X51I8RD4IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GINGERC5529G5JPQIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OACTIB
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT

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
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
ndc (package): 59088-623-08
ndc (product): 59088-623
ndc11 (package): 59088062308
spl id: 237334e4-0b88-c4b2-e063-6394a90a5540
spl set id: dc16af56-b97d-c17f-e053-2995a90a55a0

Reported adverse events (FAERS/openFDA)#

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