ARNICA  - arnica montana root ointment 
Heel Inc

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.

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Arnica Ointment 50g

ACTIVE INGREDIENTS

Active ingredients: Each 50g of ointment contains: Arnica montana, radix 3X

PURPOSE

Minor injuries, Abrasions, Bruising, Insect Bites and Stings

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

For the temporary relief of pain and swelling due to:

  • Minor Injuries
  • Abrasions
  • Bruising
  • Insect Bites and Stings

WARNINGS

Warnings: For external use only. If symptoms persist for more than a few days, consult a healthcare professional. This product contains cetyl stearyl alcohol which may cause local skin reactions. Do not use if known sensitivity to any ingredient in Arnica exists.

DOSAGE AND ADMINISTRATION

Directions for use: Apply generously 3 times daily or more often if necessary to the affected area, rubbing in gently. If appropriate, also apply an ointment dressing. To open, puncture inner protective seal with point on cap.

INACTIVE INGREDIENTS

Inactive ingredients: Cetyl stearyl alcohol, ethanol, paraffin, purified water and white petrolatum. No artificial colors, fragrance or animal products.


Arnica 50g Ointment.jpg


ARNICA  
arnica montana root ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-8000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]  in 50 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
ALCOHOL 
WATER 
PARAFFIN 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8000-81 in 1 CARTON
150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/1990
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-8000)

Revised: 7/2012
 
Heel Inc