ARNICA- arnica montana ointment

Arnica by

Drug Labeling and Warnings

Arnica by is a Homeopathic medication manufactured, distributed, or labeled by Dr. Masood Homeopathic Pharmaceuticals(Private) Limited, Dr. Masood Homeopathic Pharmaceuticals ( Private) Limited, Dr. Masood Homeopathic Pharmaceuticals (Private) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:

Adults and children over 2 years of age and older, apply generously, rubbing into the affected area
Reapply if needed
Children under two years of age, consult a physician

WARNINGS

For external use only

Do not:

• use if you have an allergy or hypersensitivity to components of the formula
• apply to wounds or damaged skin
• apply to children under two years of age

When using this product:

• avoid contact with eyes
• do not bandage tightly
• apply over large areas of the body

Stop use and ask a doctor if:

• condition worsens
• If symptoms persists for more than 7 days or clear up and again within a few days
• rash develops​

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

INDICATIONS & USAGE

Uses:

For the temporary relief of

Sores muscles, bruises, sprains as per homeopathic material medica

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

Inactive ingredients:

Carbomer 980, petrolatum, sodium hydroxide, purified water

ACTIVE INGREDIENT

Active Ingredients:

Arnica Montana

PURPOSE

Purpose:

Anti-inflammatory, Pain reliever

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA 
arnica montana ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82797-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	2 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)	0.2 g  in 20 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.03 g  in 20 g
WATER (UNII: 059QF0KO0R)	20 g  in 20 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	1 g  in 20 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82797-111-20	20 in 1 BOX	12/01/2022
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2022

Labeler - Dr. Masood Homeopathic Pharmaceuticals(Private) Limited (645453119)

Registrant - Dr. Masood Homeopathic Pharmaceuticals ( Private) Limited (645453119)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Masood Homeopathic Pharmaceuticals (Private) Limited		645453119	manufacture(82797-111) , pack(82797-111) , label(82797-111)