Label: COLD SORE COMPLEX- bryonia, calcarea sulfurica, clematis erecta, graphites, lycopodium clavatum, natrum carbonicum, natrum muriaticum liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 1, 2011

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  • Purpose:

    Suggested use for one or more of the following symptoms:

    Fever blisters, canker sores, cracked lips, scabs on chin and mouth.

  • Usage and Dosage:

    For oral use only.

  • DOSAGE & ADMINISTRATION

    Adults:

        In Acute Phase:
                12-15 drops until relief occurs
        When Relief Occurs:
                12-15 drops, 4-6 times per day

    Children 2-12 years:

                8-10 drops, 4-6 times per day

    Infants 0-24 months:

                4 drops, 4-6 times per day

  • Warnings:

    Keep out of reach of children.

  • WARNINGS

    If symptoms persist, consult a physician.

    Do not use if ring on bottom of cap is broken or missing.

  • Active Ingredients:

    Bryonia 6X, Calcarea sulfurica 8X, Clematis erecta 6X, Graphites 12X, Lycopodium clavatum 12X, Natrum carbonicum 10X, Natrum muriaticum 10X

  • Inactive Ingredients:

    Alcohol, 20% USP

  • QUESTIONS

    Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
    1-800-225-8094

  • PRINCIPAL DISPLAY PANEL

    Cold Sore Complex Product

    Cold Sore Complex Product

    Cold Sore Complex Bottle Label

    Cold Sore Complex Bottle


    Cold Sore Complex Box


    Cold Sore Complex Box


  • INGREDIENTS AND APPEARANCE
    COLD SORE COMPLEX 
    bryonia, calcarea sulfurica, clematis erecta, graphites, lycopodium clavatum, natrum carbonicum, natrum muriaticum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52731-7029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS8 [hp_X]  in 1 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP6 [hp_X]  in 1 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CARBONATE10 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52731-7029-21 in 1 BOX
    1NDC:52731-7029-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Nova Homeopathic Therapeutics, Inc. (194394540)
    Registrant - Nova Homeopathic Therapeutics, Inc. (194394540)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova Homeopathic Therapeutics, Inc.194394540manufacture, label, pack
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