ARNICA PERFORMANCE GEL- arnica montana gel

Arnica Performance Gel by

Drug Labeling and Warnings

Arnica Performance Gel by is a Otc medication manufactured, distributed, or labeled by Myo-Breathe,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Arnica Montana 15%

PURPOSE

Purpose:Trauma, bruises, stiffness, muscle soreness

 

INDICATIONS & USAGE

For relief of muscle aches and stiffness due to minor injuries such as strains, falls and blows. Reduces pain, swelling, and discoloration from bruises.

WARNINGS

Warnings: For external use only.
Avoid contact with eyes and with open wounds. Do not use on broken skin

Stop use and ask a doctor if condition persists for more than 3 days or worsens.

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

Directions: Apply Arnica Performance Gel to affected area as soon as possible after minor injury.

Repeat 3 times a day or as needed

Other Information: Store at 68-77 F (20-25 C)

Inactive Ingredients

Aloe Barbadensis, Caprylic /Capric Triglyceride, Caprylyi Glycol, Carbomer, Deionized Water, Glycerin, Ilex Paraguariensis Extract, Isoprpyl Alcohol, IsodecylNeopentanoate, Lecithin, MSM, Phenoxyethanol, Sorbic Acid, Triethanolamine & Vitamin E

Question or Comments? 1-800-803-1535

PRINCIPAL DISPLAY PANEL

                      

INGREDIENTS AND APPEARANCE

ARNICA PERFORMANCE GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41391-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
CARBOMER 934 (UNII: Z135WT9208)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41391-121-21	59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41391-121-20	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/25/2015

Labeler - Myo-Breathe,LLC (003635412)