ARNICA PAIN RELIEF- arnica montana gel

Arnica Pain Relief by

Drug Labeling and Warnings

Arnica Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by United Laboratories Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 2 years and above:
• Apply a thin layer to affected area and surrounding areas as soon as possible after injury.
• Lightly rub in and reapply after 30 seconds.
• Repeat 4 times a day for 3 to 5 days.
• When pain has subsided, apply once each morning and evening for continued temporary relief.

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:

INGREDIENTS AND APPEARANCE

ARNICA PAIN RELIEF 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62400-0034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 113 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62400-0034-1	113 g in 1 JAR; Type 0: Not a Combination Product	06/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/20/2017

Labeler - United Laboratories Manufacturing, LLC (807878116)

Establishment
Name	Address	ID/FEI	Business Operations
United Laboratories Manufacturing, LLC		807878116	manufacture(62400-0034)