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NDC 63287-0419-01 RELEEV Cold Sore Treatment 1.3 mg/mL Details

RELEEV Cold Sore Treatment 1.3 mg/mL

RELEEV Cold Sore Treatment is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Merix Pharmaceutical Corp.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	63287-0419
Product ID	63287-419_e3da5cc2-c71d-3a22-e053-2995a90adfeb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	RELEEV Cold Sore Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Merix Pharmaceutical Corp.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63287-0419-01 (63287041901)

Pricing Information	N/A
NDC Package Code	63287-419-01
Billing NDC	63287041901
Package	1 POUCH in 1 BLISTER PACK (63287-419-01) / 1 BOTTLE, DROPPER in 1 POUCH / 1 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2006-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf Details

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.

SPL UNCLASSIFIED SECTION

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	08/31/2012
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2006

Labeler - Merix Pharmaceutical Corp. (158385687)

Revised: 7/2022

Document Id: e3da5cc2-c71d-3a22-e053-2995a90adfeb

Set id: fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf

Version: 17

Effective Time: 20220715