ARNICA PERFORMANCE GEL- arnica montana gel 
Myo-Breathe,LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Drug Facts

Active Ingredient: Arnica Montana 15%

Purpose:Trauma, bruises, stiffness, muscle soreness

 

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: 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

arnica_2oz_gel.jpg                       arnica_3oz_ roll_on.jpg

ARNICA PERFORMANCE GEL 
arnica montana gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41391-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41391-121-2159 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:41391-121-2089 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/25/2015
Labeler - Myo-Breathe,LLC (003635412)

Revised: 7/2015
Document Id: 22fc0589-e2b6-4bbe-9933-bc3c64eca929
Set id: 6f4e10e9-113c-4266-aa63-bee9c2968ebf
Version: 1
Effective Time: 20150725
 
Myo-Breathe,LLC