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| Product NDC Code | 59088-623 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimopair |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 259090 | ||||
| Application Number | part347 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 5.0% Purpose Skin Protectant
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ■ apply cream liberally as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Dimopair Dimethicone DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL SAFFLOWER OIL CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID DIMETHICONE DIMETHICONE SODIUM HYDROXIDE EDETATE DISODIUM ANHYDROUS ALUMINUM STARCH OCTENYLSUCCINATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Dimopair™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ protect from freezing ■ avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API