Label: ARNICA MONTANA 30C- arnica montana liquid

  • NDC Code(s): 43406-0217-1
  • 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 February 17, 2022

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  • ACTIVE INGREDIENT

    ​ACTIVE INGREDIENT (HPUS*):

    Arnica Montana 30C

  • PURPOSE

    ​USES:​ Temporarily relieves aches, pains and bruising.**

  • INDICATIONS & USAGE

    ​USES: ​Temporarily relieves aches, pains and bruising.**

  • DOSAGE & ADMINISTRATION

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

  • 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 right away.

  • WARNINGS

    ​WARNINGS:

    • ​Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask as 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.
    • Do not use if TAMPER EVIDENT seal is broken or missing.

  • INACTIVE INGREDIENT

    ​INACTIVE INGREDIENTS: ​Purified Water, Ethyl Alcohol USP.

  • QUESTIONS

    ​QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600​​

  • REFERENCES

    *​The letters "HPUS" indicate the component in the product is officially monographed in the Homeopathic Pharmacopeia of the United States.

    **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

  • PRINCIPAL DISPLAY PANEL

    ​NDC: 43406-0217-1

    ARNICA MONTANA 30C

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    image description

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 30C 
    arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0217
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0217-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2006
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0217)
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