RELEEV COLD SORE TREATMENT - benzalkonium chloride liquid 
Topical Pharmaceuticals Inc.

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.

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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

1cc carton3cc carton6ml carton

RELEEV COLD SORE TREATMENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15478-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
Methylparaben (UNII: A2I8C7HI9T)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propylparaben (UNII: Z8IX2SC1OH)  
Echinacea purpurea flowering top (UNII: 2EMS3QFX65)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15478-001-011 in 1 BLISTER PACK
11 in 1 POUCH
11 mL in 1 BOTTLE, DROPPER
2NDC:15478-001-031 in 1 BLISTER PACK
23 mL in 1 BOTTLE, DROPPER
3NDC:15478-001-061 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)

Revised: 4/2011
Document Id: be150a40-ab7f-4e93-ae01-888076d03d40
Set id: 39a54dd2-936d-474e-a342-e1450280720c
Version: 2
Effective Time: 20110401
 
Topical Pharmaceuticals Inc.