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

  • NDC Code(s): 43406-0013-1
  • Packager: Natural Creations, Inc.
  • 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

If you are a consumer or patient please visit this version.

  • 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

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  • INDICATIONS & USAGE

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

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

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  • DO NOT USE

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

    Do not use if seal is broken or missing.

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  • REFERENCES

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

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

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  • QUESTIONS

    QUESTIONS AND COMMENTS?

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

    LOT:

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  • PURPOSE

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

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  • 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.

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  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0013-1

    COLD SORE HP

    Cold Sores

    1 fl oz (30 mL) / 20% Ethanol

    UPC: 877730000965

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  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0013
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK 30 [hp_C]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_C]  in 1 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 30 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) CHLORIDE ION 30 [hp_C]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 30 [hp_C]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C]  in 1 mL
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS 30 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_C]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43406-0013-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    Name Address ID/FEI Business Operations
    OHM Pharma, Inc. 030572478 manufacture(43406-0013)
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