Label: COLD SORE HP- juglan cinerea branch bark/root bark, potassium iodide, lycopodium clavatum spore, mercury, sodium chloride, nitric acid, phosphorus, ranunculus bulbosus, toxicodendron pubescens leaf, sepia officinalis juice, thuja occidentalis leafy twig 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 October 18, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Juglans Cinerea 30C, Kali Iodatum 30C, Lycopodium Clavatum 30C, Mercurius Vivus 30C, Natrum Muriaticum 30C, Nitricum Acidum 30C, Phosphorus 30C, Ranunculus Bulbosus 30C, Rhus Toxicodendron 30C, Sepia 30C, Thuja Occidentalis 30C

  • INDICATIONS & USAGE

    USES: Temporarily relieves pustules, skin ulcerations, dry cracked skin with soreness, &/or symptoms related to herpes sores.

  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • DO NOT USE

    OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

    Do not use if seal is broken or missing.

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

    LOT:

  • PURPOSE

    USES: Temporarily relieves pustules, skin ulcerations, dry cracked skin with soreness, &/or symptoms related to herpes sores.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion (get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0013-1

    COLD SORE HP

    Cold Sores

    1 fl oz (30 mL) / 20% Ethanol

    UPC: 877730000965

    Image Of Label

  • INGREDIENTS AND APPEARANCE
    COLD SORE HP 
    juglan cinerea branch bark/root bark, potassium iodide, lycopodium clavatum spore, mercury, sodium chloride, nitric acid, phosphorus, ranunculus bulbosus, toxicodendron pubescens leaf, sepia officinalis juice, thuja occidentalis leafy twig liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK30 [hp_C]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY30 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) CHLORIDE ION30 [hp_C]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID30 [hp_C]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 1 mL
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS30 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0013-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0013)
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