Label: RELEEV COLD SORE TREATMENT- benzalkonium chloride liquid
- NDC Code(s): 63287-419-01, 63287-419-03, 63287-419-06, 63287-419-33
- Packager: Merix Pharmaceutical Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 15, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Uses:
-
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
- Directions:
- Inactive Ingredients:
- Other Information:
- Packaging
-
INGREDIENTS AND APPEARANCE
RELEEV COLD SORE TREATMENT
benzalkonium chloride liquidProduct 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 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 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)