RELEEV Cold Sore Treatment: Package Insert and Label Information

RELEEV COLD SORE TREATMENT- benzalkonium chloride liquid
Merix Pharmaceutical Corp.

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.

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
(click image for full-size original)

RELEEV COLD SORE TREATMENT
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63287-419
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (4000 MPA.S)
ECHINACEA PURPUREA FLOWERING TOP
METHYLPARABEN
POTASSIUM SORBATE
WATER
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63287-419-01 1 POUCH in 1 BLISTER PACK contains a POUCH
1 1 BOTTLE, DROPPER in 1 POUCH This package is contained within the BLISTER PACK (63287-419-01) and contains a BOTTLE, DROPPER
1 1 mL in 1 BOTTLE, DROPPER This package is contained within a POUCH and a BLISTER PACK (63287-419-01)
2 NDC:63287-419-03 1 BOTTLE, DROPPER in 1 BLISTER PACK contains a BOTTLE, DROPPER
2 3 mL in 1 BOTTLE, DROPPER This package is contained within the BLISTER PACK (63287-419-03)
3 NDC:63287-419-06 1 BOTTLE, DROPPER in 1 BLISTER PACK contains a BOTTLE, DROPPER
3 6 mL in 1 BOTTLE, DROPPER This package is contained within the BLISTER PACK (63287-419-06)
4 NDC:63287-419-33 1 BOTTLE, DROPPER in 1 BLISTER PACK contains a BOTTLE, DROPPER
4 3 mL in 1 BOTTLE, DROPPER This package is contained within the BLISTER PACK (63287-419-33)
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 Operations
Topical Pharmaceuticals Inc. 831530683 manufacture (63287-419)

Revised: 01/2020 Merix Pharmaceutical Corp.

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