ARNICA- arnica montana flower, calendula officinalis flower, hamamelis virginiana leaf, and chamomile stick

ARNICA by

Drug Labeling and Warnings

ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by ONA STICK USA LLC, Abinter Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Arnica montana (Arnica), 1X, 2.5%; Calendula officinalis (Calendula), 1X, 1.8%; Hamamelis virginiana (Witch Hazel), 1X, 2.5%; Matricaria chamomilla (Chamomile), 1X, 2.0%	For relief of minor pain, discomfort, bumps & bruises

Uses1

Temporarily relieves minor pain, discomfort, bumps and bruises due to minor injuries, falls, trauma and overexertion.

1 As a homeopathic medicine, these "Uses" have not been evaluated by the Food & Drug Administration.

Warnings

For external use only.

Do not use if you are allergic to any of the active ingredients or inactive ingredients in this product.

When using this product

• avoid contact with eyes and mouth
• do not use on wounds or irritated or damaged skin
• use only as directed
• do not apply tight wraps or bandages to treated areas
• do not apply heat to treated areas immediately before or after use

Stop use and ask a doctor if

• symptoms persist more than 3 days or worsen
• symptoms clear up and then reoccur within a few days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Apply a thin layer to affected areas, massaging onto skin. Repeat as needed. If heat or ice are applied to skin, wait 10 minutes before applying product.

Other information

Keep cap firmly in place between uses. Store at room temperature in a dry place. Retain this tip card for full Drug Facts.

Inactive ingredients

Beeswax, Carnauba Oil, Castor Oil, Cocoa Butter, Coconut Oil, Isopropyl Myristate, Lanolin, Mineral Oil, Oleic Acid, Ozoquerite Wax, Stearyl Alcohol.

Questions

call 210.629.1343

SPL UNCLASSIFIED SECTION

Distributed by
Ona stick
Magnolia, Tx, 77354

PRINCIPAL DISPLAY PANEL - 14 g Tube Blister Pack

CHAMOMILE CALENDULA WITCH HAZEL

Natural active
ingredients

arnica

oná stick®
Pain & bruise balm
Homeopathic medicine

| Wellness at hand.

Goodbye bruises!

Pain & bruise balm
Homeopathic medicine

NET WT 0.5 oz (14 g)

INGREDIENTS AND APPEARANCE

ARNICA 
arnica montana flower, calendula officinalis flower, hamamelis virginiana leaf, and chamomile stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82610-003
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	1 [hp_X]  in 14 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 14 g
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	1 [hp_X]  in 14 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X]  in 14 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
Cocoa Butter (UNII: 512OYT1CRR)
Coconut Oil (UNII: Q9L0O73W7L)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Lanolin (UNII: 7EV65EAW6H)
Mineral Oil (UNII: T5L8T28FGP)
Oleic Acid (UNII: 2UMI9U37CP)
CERESIN (UNII: Q1LS2UJO3A)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82610-003-14	1 in 1 BLISTER PACK	03/15/2022
1		14 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		03/15/2022

Labeler - ONA STICK USA LLC (118525613)

Establishment
Name	Address	ID/FEI	Business Operations
Abinter Labs LLC		117981053	MANUFACTURE(82610-003)