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 January 2, 2020

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  • 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 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.

  • 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

  • INGREDIENTS AND APPEARANCE
    RELEEV COLD SORE TREATMENT 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-419
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63287-419-011 in 1 BLISTER PACK06/01/2006
    11 in 1 POUCH
    11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:63287-419-031 in 1 BLISTER PACK06/01/2006
    23 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:63287-419-061 in 1 BLISTER PACK06/01/2006
    36 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:63287-419-331 in 1 BLISTER PACK08/21/2018
    43 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2006
    Labeler - Merix Pharmaceutical Corp. (158385687)
    Registrant - Topical Pharmaceuticals Inc. (831530683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceuticals Inc.831530683manufacture(63287-419)