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| Product NDC Code | 70084-500 | ||||
|---|---|---|---|---|---|
| Drug Name | Canker care plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1812747, 1812752 |
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| Application Number | part356 | ||||
| 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 0.5%
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 to affected area up to 4 times a day, or as directed by a doctor or dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice (Aloe Vera Gel), Calendula Officinalis Extract, Cellulose Gum, Commiphora Myrrha (Myrrh) Extract, Cyanocobalamin (Vitamin B12), Dipotassium Glyrrhizinate (DGL, Licorice), Echinacea Purpurea Extract, Eugenia Ceryophyllus (Clove Bud) Oil, Glycerine, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Leucadendron (Cajuputi) Oil, Mentha Piperita (Peppermint) Oil, Castor Oil, Polysorbate 20, Propolis Extract,Purified Water, Zinc
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 For the temporary relief of mouth pain associated with canker sores, toothache, dentures, braces or cheek bites.
Purpose
Information about the drug product’s indications for use.Purpose Oral Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Canker Care Plus Menthol, Unspecified Form Menthol, Unspecified Form Menthol, Unspecified Form Echinacea Purpurea Whole TEA TREE OIL MELALEUCA CAJUPUTI LEAF OIL GOLDENSEAL LYSINE HYDROCHLORIDE PROPOLIS WAX Water Castor Oil CYANOCOBALAMIN Zinc Gluconate Carboxymethylcellulose Sodium, Unspecified MYRRH GLYCYRRHIZINATE DIPOTASSIUM CLOVE OIL Glycerin Licorice Peppermint Oil Polysorbate 20 Calendula Officinalis Flower
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 - 9.4 mL Bottle Carton Quantum ® HEALTH Canker Care + ® Oral Gel Pain Reliever IMMEDIATE PAIN RELIEF SOOTHING PROTECTIVE GEL FRESH NATURAL TASTE WITH 15 NUTRIENTS INCLUDING LYSINE, LICORICE, ALOE VERA, PROPOLIS AND TEA TREE OIL. GENTLE BRUSH APPLICATOR .33 FL OZ / 9.4 mL PRINCIPAL DISPLAY PANEL - 9.4 mL Bottle 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 this and all drugs out of the reach of children.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if shrink wrap seal covering bottle and cap is broken or missing.
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 Do not use this product for more than 7 days unless directed by a health professional. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness worsens; or if swelling, rash or fever develops; see your doctor or dentist. Do not exceed recommended dosage. Avoid contact with eyes. Keep this and all drugs out of the reach of children.
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