RELEEV COLD SORE TREATMENT- benzalkonium chloride liquid

RELEEV Cold Sore Treatment by

Drug Labeling and Warnings

RELEEV Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Merix Pharmaceutical Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

INGREDIENTS AND APPEARANCE

RELEEV COLD SORE TREATMENT 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63287-419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63287-419-01	1 in 1 BLISTER PACK	06/01/2006
1		1 in 1 POUCH
1		1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 63287-419-03	1 in 1 BLISTER PACK	06/01/2006
2		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 63287-419-06	1 in 1 BLISTER PACK	06/01/2006
3		6 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 63287-419-33	1 in 1 BLISTER PACK	08/21/2018
4		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2006

Labeler - Merix Pharmaceutical Corp. (158385687)

Registrant - Topical Pharmaceuticals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(63287-419)