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| Product NDC Code | 82800-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Prequel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1044967 | ||||
| Application Number | M016 | ||||
| Labeler Name | The Center Brands, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Petrolatum 45.00%
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 as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Parrafinum Liquidum, Ozokerite, Dimethicone, Brassica Campestric/Aleuites Fordi Oil Copolymer, Bisabolol, Cetylhydroxyproline Palmitamide, Oryza Sativa Bran Extract, Helianthus Annuus Extract, Tocopherol, Rosmarinus Officinalis Leaf Extract, Stearic Acid, Brassica Campestris Sterols, 1,2-Hexanediol, Hexyldecanol
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 releive chafed, chapped or craked skin and lips •Temporarily protects minor: •cuts •scrapes •burns •Helps protect form 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.Prequel Multi Purpose Skin Protectant MINERAL OIL DIMETHICONE HEXYLDECANOL CERESIN RAPESEED STEROL ROSEMARY STEARIC ACID SUNFLOWER SEED TOCOPHEROL 1,2-HEXANEDIOL BRASSICA RAPA SUBSP. OLEIFERA OIL LEVOMENOL CETYLHYDROXYPROLINE PALMITAMIDE RICE BRAN PETROLATUM PETROLATUM
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.Principal Display Panel 82800-008
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Visit prequelskin.com
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 swalled, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
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 Fox external use only. 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. Do not use on • deep or puncture woulds • animal bites • serious burns.
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