7 SELECT COLD SORE SYMPTOM TREATMENT- benzalkonium chloride solution

7 SELECT Cold Sore Symptom Treatment by

Drug Labeling and Warnings

7 SELECT Cold Sore Symptom Treatment by is a Otc medication manufactured, distributed, or labeled by 7-eleven, Topical Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium chloride

(an organic chloride salt) 0.13%

Purpose

Cold Sore/Fever Blister Treatment

INDICATIONS & USAGE

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 sores & fever blisters. May be used inside the mouth on sores.

WARNINGS

Warnings: Do not swallow. Do not use if allergic to Asteracea (daisy) family of flowers. Do not use for yeast infections (may be used in conjuction with yeast medication). Use only as directed. For external use only. Brief tingling may occur. If conditions worsens or does not improve, contact a health care professional. Avoid contact with eyes. WE SUGGEST THAT YOU NOT USE ALCOHOL DURING AN OUTBREAK OR WHEN USING THIS PRODUCT.

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.

DOSAGE & ADMINISTRATION

Directions: (adults and children 2 years of age or older) Intended as a 1-day cold sore symptom treatment, apply to clean, dry, affected area 3-4 times throughout the 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. Due to the natural ingredients in this product, color may vary. Product dries clear. SHAKE WELL.

INACTIVE INGREDIENT

Other Ingredients: Purified Water, Viracea, (proprietary blend of Benzalkonium Chloride and Echinacea herb (organic), Hypromellose, Methyl Paraben, Potassium Sorbate, Propyl Paraben.

STORAGE AND HANDLING

Other Information: May be stored in refrigerator for longer shelf life. Do not freeze. Do not overheat.

QUESTIONS

Questions or comments?1-844-428-2538

SPL UNCLASSIFIED SECTION

Fastest Healing Time Guaranteed!

Relieves Symptoms in Just a Day!

Soothing

Non-Irritating

Patented Viracea Formula

1 DAY Cold Sore Symptom Treatment

Scientific publications regarding this product can be obtained by contacting:

Merix Pharmaceutical Corp.

Satisfaction Guaranteed

1-800-255-0711

Packaging

INGREDIENTS AND APPEARANCE

7 SELECT COLD SORE SYMPTOM TREATMENT 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10202-591
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
WATER (UNII: 059QF0KO0R)
ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10202-591-90	1 in 1 BLISTER PACK	06/03/2016
1		1 mL in 1 BOTTLE; 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	06/03/2016

Labeler - 7-eleven (007347602)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals, Inc		831530683	manufacture(10202-591)