Active Ingredient
Benzalkonium chloride 0.13%
Releev Cold Sore Treatment Liquid
FDA Label NDC 63287-419
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Merix Pharmaceutical Corp. for the product Releev Cold Sore Treatment (NDC 63287-419). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cold Sore/ Fever Blister Treatment
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.
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.
Otc - Keep Out Of Reach Of Children
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.
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 Ingredients:
Echinacea Purpurea [Viracea®, proprietary blend of Benzalkonium Chloride and Echinacea herb], Methyl Cellulose, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified Water,
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.
Packaging
Releev (Reelev 1)
* Please review the disclaimer below.
