ARNICA ACTIVE- arnica montana, calendula officinalis flowering top, hypericum perforatum and symphytum officinale whole spray

Arnica Active by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Arnica montana 4X      

Purpose

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

Active Ingredient

Calendula officinalis 4X      

Purpose

bruises, swelling

Active Ingredient

Hypericum perforatum 4X      

Purpose

aches, muscle soreness, strains

Active Ingredient

Symphytum officinale 6X      

Purpose

sores, sprains, bruises

Uses:

According to homeopathic principles, the active ingredients in this medication help temporarily relieve minor aches and pains of muscles and joints associated with:

• bruising & swelling
  
• sprains
  
• backaches
  
• muscular aches & pains
  
• strains
  
• stiffness

Warnings:

• FOR EXTERNAL USE ONLY. Do not use on open wounds or mucous membranes.
  
• Initial exacerbation of symptoms may occur.
  
• Avoid contact with the eyes.
  
• Do not use in case of known hypersensitivity to Asteracea.
  
• 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 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:

Spray on the injured part of the body 2-3 times a day, or use as a compress. Saturate a clean cloth or gauze compress, place on wound and secure with a bandage. Change dressing 2-3 times a day.

Other Information:      

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Alcohol, 27%

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NEW
NDC 59262-101-41
Similasan
Arnica
ActiveTM 
SKIN SPRAY
90 mL/3.04 fl oz

INGREDIENTS AND APPEARANCE

ARNICA ACTIVE 
arnica montana, calendula officinalis flowering top, hypericum perforatum and symphytum officinale whole spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 90 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X]  in 90 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	4 [hp_X]  in 90 mL
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	6 [hp_X]  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-101-41	1 in 1 BOX
1		90 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		03/27/2014

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan AG		481545754	LABEL(59262-101) , MANUFACTURE(59262-101) , PACK(59262-101)