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Product NDC Code | 63287-419 | ||||||||
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Drug Name | Releev cold sore treatment |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LIQUID | ||||||||
RxCUI drug identifier | 1049254, 1095485 |
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Application Number | part333A | ||||||||
Labeler Name | Merix Pharmaceutical Corp. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 0.13% Purpose Cold Sore/ Fever Blister Treatment
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: SHAKE WELL (Adults and children 12 years of age or older) apply to clean, dry, affected area 3-4 times per day by dabbing and pressing solution into the area well. Allow to dry. Best when used at first sign of outbreak. Do not use cotton applicator.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Echinacea Purpurea [Viracea®, proprietary blend of Benzalkonium Chloride and Echinacea herb], Methyl Cellulose, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified Water,
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: Treats cold sores/ fever blisters. For the pain, tingling, itching, & burning associated with cold sores. May be used as an antiseptic to help cleanse or dry cold sores & fever blisters. May be used inside the mouth on sores.
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.RELEEV Cold Sore Treatment Benzalkonium Chloride HYPROMELLOSE 2910 (4000 MPA.S) ECHINACEA PURPUREA FLOWERING TOP METHYLPARABEN POTASSIUM SORBATE WATER PROPYLPARABEN BENZALKONIUM CHLORIDE BENZALKONIUM
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.Packaging RELEEV
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 reach of children . In case of accidental ingestion other than intended use, seek professional assistance or call a poison control center.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: We suggest that you not consume alcohol during an outbreak or when using this product. Due to the natural ingredients in this product, colour may vary. Product dries clear.
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: • If you have ever had an allergic reaction to this product or any of its ingredients. • Do not swallow. • Do not use for yeast infections (may be used in conjunction with yeast medication). • Avoid contact with eyes. • If condition worsens or does not improve, contact a health care professional. When Using This Product • Use only as directed • Brief tingling may occur.
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