DIMOPAIR- dimethicone cream 
PureTek Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dimopair

Active ingredient

Dimethicone 5.0%

Purpose

Skin Protectant

Uses

■ temporarily protects and helps relieve chapped or cracked skin

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

Warnings

For external use only

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product

■ 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.

Directions

■ apply cream liberally as needed

Other information

■ protect from freezing ■ avoid excessive heat

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

Inactive ingredients

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™

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

Label

DIMOPAIR 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-623
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GINGER (UNII: C5529G5JPQ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-623-08118 mL in 1 TUBE; Type 0: Not a Combination Product03/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/29/2023
Labeler - PureTek Corporation (785961046)

Revised: 4/2023
Document Id: f94f2eac-1161-10bb-e053-6294a90a8f49
Set id: dc16af56-b97d-c17f-e053-2995a90a55a0
Version: 2
Effective Time: 20230414
 
PureTek Corporation