Label: COLD SORE FREE (sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil- pinus sylvestris thuja occidentalis root salve

  • 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 March 3, 2020

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

    ORGANIC ECHINACEA ANGUSTIFOLIA (2X) HPUS

    ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

    PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

    THUJA OCCIDENT (6X) HPUS

  • PURPOSE

    PROPERTIES

    ANTI-INFLAMMATORY

    ANTI-VIRAL

    SKIN PROTECTANT

    SKIN PROTECTANT

    RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES AND CANKER SORES. USE ORALLY OR GENITALLY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO AFFECTED AREA 3-8 TIMES PER DAY AS NEEDED. MAY BE APPLIED GENITALLY. ALSO APPLY DAILY AS A PREVENTIVE MEASURE.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, BALSAM FIR, WILD HARVESTED DRAGONS BLOOD (SANGRE DE GRADO).

  • WARNINGS

    WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • OTHER SAFETY INFORMATION

    STORE IN A COOL DRY PLACE OR REFRIGERATE

  • PRINCIPAL DISPLAY PANEL

    cold sore 1 oz

  • INGREDIENTS AND APPEARANCE
    COLD SORE FREE 
    sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil (pinus sylvestris) thuja occidentalis root salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA2 [hp_X]  in 100 mL
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 mL
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y) PINE NEEDLE OIL (PINUS SYLVESTRIS)1 [hp_X]  in 100 mL
    THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3) THUJA OCCIDENTALIS ROOT6 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-301-1130 mL in 1 JAR; Type 0: Not a Combination Product10/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-301)