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Releev Cold Sore Treatment by Topical Pharmaceuticals Inc.

Medically reviewed on April 2, 2018

Dosage form: liquid
Ingredients: Benzalkonium Chloride 1.3mg in 1mL
Labeler: Topical Pharmaceuticals Inc.
NDC Code: 15478-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUGS FACTS

Active ingredients

Benzalkonium chloride .13%

USE

Treat cold sores/ fever blister. For the pain, tingling, itching, and the burning association with cold sore. May be used as an antiseptic to help cleases or dry cold sores, and fever blister.May be used inside the mouth on sores, and fever blister

Warnings

Do not swallow.Do not use if allergic to Asteracea ( daisy) family flower. Do not use for yeast infections.May be used in conjunction with yeast infections. Uses only as directed. For external used only.Brief tingling may improve, contact a health care professional. Avoid contact with eyes. We suggest that you not used alcohol, during an outbreak, or when using this product.

Keep this and all drug out of reach of children.

Directions

Adult and children 2 years of age and older. Intended as a 1 day cold sore symptom treatment, apply Releev to clean dry affected area 3-4 times throughout the day by dabbing and pressing solution into area well.

Allow to dry.Best when used at first sign of outbreak. Do not use applicator. do to the natural ingredients in this product color may vary. Product dries clear.

Purified water, Viracea Proprietary Echinacea herb extract, Methyl cellusose, Methyl Paraben, Potassium sorbate, Propyl Paraben.

releev carton

RELEEV COLD SORE TREATMENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15478-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
HYPROMELLOSE 2910 (4000 MPA.S) 
Methylparaben 
Potassium Sorbate 
Propylparaben 
Echinacea purpurea flowering top 
Packaging
#Item CodePackage Description
1NDC:15478-001-011 POUCH (POUCH) in 1 BLISTER PACK
11 BOTTLE, DROPPER (BOTTLE) in 1 POUCH
11 mL in 1 BOTTLE, DROPPER
2NDC:15478-001-031 BOTTLE, DROPPER (BOTTLE) in 1 BLISTER PACK
23 mL in 1 BOTTLE, DROPPER
3NDC:15478-001-061 BOTTLE, DROPPER (BOTTLE) in 1 BLISTER PACK
36 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2006
Labeler - Topical Pharmaceuticals Inc. (831530683)

 
Topical Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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