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| Product NDC Code | 70084-420 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Super lysine plus |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1812680, 1812685 |
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| Application Number | part341 | ||||||
| Labeler Name | Quantum, Inc. | ||||||
| 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 Ingredient Menthol 0.1%
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 For adults and children 2 and older. Apply liberally as needed. For best results, apply every 2 hours. Wash hands before and after applying.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Beeswax, Calendula Officinalis Extract, Echinacea Purpurea Extract, Gum Benzoin Tincture, Honey, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia Oil, Melaleuca Cajuputi Oil, Olea Europaea (Olive) Fruit Oil, Propolis Extract, Vitamin A (Retinyl Palmitate), Vitamin D3, Vitamin E (Tocopherol), Zinc Oxide.
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 Relieves tingling, itching, burning, blistering, and pain associated with cold sores/fever blisters.
Purpose
Information about the drug product’s indications for use.Purpose Cold sore / fever blister treatment
Spl product data elements
Usually a list of ingredients in a drug product.Super Lysine plus Menthol, Unspecified Form Menthol, Unspecified Form Menthol, Unspecified Form Calendula Officinalis Flower Echinacea Purpurea BENZOIN RESIN HONEY GOLDENSEAL LYSINE HYDROCHLORIDE TEA TREE OIL MELALEUCA CAJUPUTI LEAF OIL OLIVE OIL PROPOLIS WAX VITAMIN A PALMITATE CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ZINC OXIDE Yellow Wax Olive Green
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 - 7 g Tube Carton Quantum ® HEALTH SuperLysine + ® Cold Sore Treatment CUTS HEALING TIME IN HALF* SOOTHES & MOISTURIZES RELIEVES PAIN, BURNING, & ITCHING LYSINE PLUS PROPOLIS, OLIVE OIL, VITAMIN E, & 10 OTHER NUTRIENTS Ointment NET WT 7g / .25 OZ PRINCIPAL DISPLAY PANEL - 7 g Tube Carton
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.Drug Facts
DISTRIBUTED BY: QUANTUM, INC. PO BOX 2791, EUGENE, OR 97402
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; or symptoms last more than 7 days or clear up and occur again
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 Store at room temperature and avoid excessive heat. Close cover tightly after each use.
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. When using this product do not get into eyes. Stop use and ask a doctor if condition worsens; or symptoms last more than 7 days or clear up and occur again 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