Label: ARNICA GEL- arnica montana gel

  • 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 17, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts__________________________________________________________________________________________________________

    Active ingredient:

    Arnica montana 1X HPUS*-7%

    *HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

  • INDICATIONS & USAGE

    Uses Temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.

  • WARNINGS

    Warnings:

    • For external use only. Avoid contact with eyes and broken skin.
    • If pregnant or breast-feeding, ask a health professional before use.
    • Nursing mothers should not apply to breast area.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
    • Stop use and ask a doctor if: •symptoms worsen or do not improve within 3 days •skin irritation, redness or rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply at the onset of symptoms.

  • OTHER SAFETY INFORMATION

    Other information:

    • Do not use if carton or tube seal is broken.
    • Store at 68-77°F (20-25°C).
    • Keep carton for complete drug facts and product information.
  • INACTIVE INGREDIENT

    Inactive ingredients:  Alcohol denat, carbomer, purified water, sodium hydroxide.

  • PURPOSE

    Drug Facts

    ____________________________________________________________________________________________________________________

    Active ingredients                                   Purpose†

    Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion.

    *HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ARNICA GEL 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-3203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 73 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-3203-31 in 1 CARTON
    173 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/07/2016
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-3203)