Label: ARNIFLORA- arnica montana gel

  • NDC Code(s): 53499-5090-4, 53499-5090-8
  • Packager: Schwabe North America, 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 September 22, 2023

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  • Active Ingredient

    ARNICA MONTANA  1X 

  • Inactive Ingredient

    carbomer

    ethyl alcohol

    purified water

    sodium hydroxide

    witch hazel distillate

  • Dosage and Administration

    Directions

    Apply thin layer to affected area. Massage gently or use compress.

    For best results, use promptly after injury or trauma occurs

    Adults and children 6 years of age and older: apply to affected area up to 4 times daily

    Patch test recommened on sensitive skin

  • Indications & Usage

    Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

    Reduces pain, swelling, and discoloration from bruises.

  • Purpose

    Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

    Reduces pain, swelling, and discoloration from bruises.

  • Warnings

    For external use only.

    Avoid contact with eyes and broken skin.

  • Do not use

    Do not use if hypersensitive to any ingredients in this product, in breast area when breast-feeding.

  • Stop Use

    Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

    These could be signs of a serious condition.

  • Pregnant or breast feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • Overdose

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    LBN21825097_07_Arniflora_2_75oz_CTN_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    ARNIFLORA  
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5090-41 in 1 CARTON01/01/201105/31/2026
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53499-5090-81 in 1 CARTON01/01/2011
    278 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2011
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-5090)
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