Active Ingredient
Dimethicone 5.0%
Dimopair Cream
FDA Label NDC 59088-623
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Dimopair (NDC 59088-623). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (Label)
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