Label: ARNICA MONTANA liquid

  • NDC Code(s): 15631-2600-0, 15631-2600-1
  • Packager: Rxhomeo Private Limited d.b.a. Rxhomeo, 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 March 19, 2024

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  • ACTIVE INGREDIENT

    ARNICA MONTANA HPUS 3X and higher

  • USES

    USES: Temporary Relief - Bruises, Aches, Pains*

    * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.

    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA

  • PRINCIPAL DISPLAY PANEL

    Product Label

    Carton Box

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-2600-010 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2024
    2NDC:15631-2600-130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/19/2024
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2600) , label(15631-2600)
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