7 SELECT COLD SORE SYMPTOM TREATMENT (BENZALKONIUM CHLORIDE) SOLUTION [7-ELEVEN]

7 SELECT COLD SORE SYMPTOM TREATMENT (BENZALKONIUM CHLORIDE) SOLUTION [7-ELEVEN]
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NDC 10202-591-90
Set ID 9f73cae2-7bfe-43fc-aaf0-b06cdb51f51b
Category HUMAN OTC DRUG LABEL
Packager 7-eleven
Generic Name
Product Class
Product Number
Application Number PART333A
  • Drug Facts

  • Active Ingredient

    Benzalkonium chloride

    (an organic chloride salt) 0.13%

  • Purpose

    Cold Sore/Fever Blister Treatment

  • INDICATIONS & USAGE

    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 sores & fever blisters. May be used inside the mouth on sores.

  • WARNINGS

    Warnings: Do not swallow. Do not use if allergic to Asteracea (daisy) family of flowers. Do not use for yeast infections (may be used in conjuction with yeast medication). Use only as directed. For external use only. Brief tingling may occur. If conditions worsens or does not improve, contact a health care professional. Avoid contact with eyes. WE SUGGEST THAT YOU NOT USE ALCOHOL DURING AN OUTBREAK OR WHEN USING THIS PRODUCT.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions: (adults and children 2 years of age or older) Intended as a 1-day cold sore symptom treatment, apply to clean, dry, affected area 3-4 times throughout the 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. Due to the natural ingredients in this product, color may vary. Product dries clear. SHAKE WELL.

  • INACTIVE INGREDIENT

    Other Ingredients: Purified Water, Viracea, (proprietary blend of Benzalkonium Chloride and Echinacea herb (organic), Hypromellose, Methyl Paraben, Potassium Sorbate, Propyl Paraben.

  • STORAGE AND HANDLING

    Other Information: May be stored in refrigerator for longer shelf life. Do not freeze. Do not overheat.

  • QUESTIONS

    Questions or comments?1-844-428-2538

  • SPL UNCLASSIFIED SECTION

    Fastest Healing Time Guaranteed!

    Relieves Symptoms in Just a Day!

    Soothing

    Non-Irritating

    Patented Viracea Formula

    1 DAY Cold Sore Symptom Treatment

    Scientific publications regarding this product can be obtained by contacting:

    Merix Pharmaceutical Corp.

    Satisfaction Guaranteed

    1-800-255-0711

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    7 SELECT COLD SORE SYMPTOM TREATMENT 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-591
    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)  
    ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10202-591-901 in 1 BLISTER PACK06/03/2016
    11 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2016
    Labeler - 7-eleven (007347602)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceuticals, Inc831530683manufacture(10202-591)

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