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RELEEV Cold Sore Treatment

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1mL
Labeler: Merix Pharmaceutical Corp.
NDC Code: 63287-419

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.

RELEEV 1 day Cold sore Symptom Treatment

Active ingredient

Benzalkonium chloride  0.13%

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.

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 COLD SORE TREATMENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-419
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
HYPROMELLOSE 2910 (4000 MPA.S) 
ECHINACEA PURPUREA FLOWERING TOP 
METHYLPARABEN 
POTASSIUM SORBATE 
WATER 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:63287-419-011 POUCH in 1 BLISTER PACK
11 BOTTLE, DROPPER in 1 POUCH
11 mL in 1 BOTTLE, DROPPER
2NDC:63287-419-031 BOTTLE, DROPPER in 1 BLISTER PACK
23 mL in 1 BOTTLE, DROPPER
3NDC:63287-419-061 BOTTLE, DROPPER in 1 BLISTER PACK
36 mL in 1 BOTTLE, DROPPER
4NDC:63287-419-331 BOTTLE, DROPPER in 1 BLISTER PACK
43 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2006
Labeler - Merix Pharmaceutical Corp. (158385687)
Registrant - Topical Pharmaceuticals Inc. (831530683)
Establishment
NameAddressID/FEIOperations
Topical Pharmaceuticals Inc.831530683manufacture(63287-419)

 
Merix Pharmaceutical Corp.

Medically reviewed on Aug 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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