ARNICA ACTIVE ROLL-ON- arnica montana liquid

Arnica Active Roll-On by

Drug Labeling and Warnings

Arnica Active Roll-On by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Arnica Active® Roll-On

Drug Facts

Active Ingredients

Arnica montana 1X

Purpose

bruises, swelling, aches, sprains, muscle pain, soreness, and stiffness

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
bruising & swelling
sprains
backaches
muscular aches & pains
strains
stiffness

Warnings

FOR EXTERNAL USE ONLY. Do not use on damaged skin, open wounds, or mucous membranes.

According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

Avoid contact with the eyes.

Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients.

Do not bandage tightly or use with a heating pad.

If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

For adults and children age 2 and over:

Apply a thin layer to affected area soon as possible after minor injury. Repeat 3 times a day or as needed.

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

USP water, carbomer, sodium hydroxide, USP ethanol, PEG-8 dimethicone

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

PRINCIPAL DISPLAY PANEL

NDC: 59262-102-42
Similasan
Arnica
Active
Roll-On
Pain Relief
74 ml/ 2.5 fl oz

INGREDIENTS AND APPEARANCE

ARNICA ACTIVE ROLL-ON 
arnica montana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-102-42	74 mL in 1 APPLICATOR; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2017

Labeler - Similasan Corporation (111566530)