ARNICA PAIN RELIEF- arnica montana gel 
Magni Group

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 Pain Relief

Drug Facts

Active ingredient

Mountain arnica (Arnica montana) 3X HPUS

The letters 'HPUS' indicate thant the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

Pain reliever

Use

temporarily relieves minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, arthritis, and bruises.

Warnings

For external use only.

Avoid contact with eyes.

Do not use

  • on open wounds 
  • cuts 
  • damaged skin
  • infected skin.

Stop use and ask a doctor if

symptoms persist for more than 7 days or worsens.

Keep out of reach of children.

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

Directions

Other information:

Store tightly closed in a cool, dry place.

Inactive ingredients

Aloe vera leaf juice, benzoic acid, carbomer 940, emu oil, eucalyptus oil, glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, sodium hydroxide, sorbic acid

Package Labeling:

Label

ARNICA PAIN RELIEF 
arnica montana gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 113 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EMU OIL (UNII: 344821WD61)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43689-0034-1113 g in 1 JAR; Type 0: Not a Combination Product06/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/20/2017
Labeler - Magni Group (113501902)

Revised: 11/2022
Document Id: ed7e2848-d523-6639-e053-2995a90a1722
Set id: f2aa46f7-1784-4adf-a297-437b47c55c87
Version: 4
Effective Time: 20221115
 
Magni Group