ARNICARE ARTHRITIS- arnica montana, harpagophytum procumbens root, harpagophytum zeyheri root cream

ARNICARE ARTHRITIS by

Drug Labeling and Warnings

ARNICARE ARTHRITIS by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients**

Arnica montana 1X HPUS 7%

Harpagophytum 1X HPUS 3%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Purpose*

Arnica montana 1X HPUS 7% ... Relieves minor muscle pain and stiffness, discoloration from bruises

Harpagophytum 1X HPUS 3% ... Relieves minor joint discomfort and stiffness

INDICATIONS & USAGE

Uses*

temporarily relieves minor joint and muscle pain and stiffness due to:

arthritis
minor injuries
overexertion
falls
repetitive motions

WARNINGS

For external use only.

DO NOT USE

• if you are allergic to Arnica montana, Harpagophytum or to any of this product's inactive ingredients
• with other topical products for pain

WHEN USING

• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
• use only as directed
• dryness or irritation may occur
• do not tightly wrap or bandage the treated area
• do not apply heat or ice to the treated area immediately before or after use

STOP USE

Stop use and ask a doctor if

• ​conditions persists for more than 7 days or worsens
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years of age and older: Apply a thin layer of Arnicare Arthritis to affected area as soon as possible at the onset of symptoms up to 4 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Arthritis.
• Children under 12 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

• do not use if glued carton end flaps are open or if the tube seal is broken
• store below 77° F (25° C)
• do not use if pouch is torn or open
• dispose of 1 day after opening

INACTIVE INGREDIENT

acrylamide/sodium acryloyldimethyltaurate copolymer , alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sorbitan oleate, sweet almond oil

QUESTIONS

Questions or comments?

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

0.18 oz (5 g)

0.5 oz (14 g)

2.5 oz (70 g)

4.2 oz (120 g)

Joint & Arthritis Pain Relief*

Quickly-Absorbed

Fragrance-Free

No Known Drug Interactions

Dual Action Pain Relief*

4.2 oz (120g) Pump:

HOW TO OPEN

1 Pull to remove safety clip from pump.

2 Twist top clockwise to open.

3 Pump until cream dispense.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE ARTHRITIS 
arnica montana, harpagophytum procumbens root, harpagophytum zeyheri root cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89)	HARPAGOPHYTUM PROCUMBENS ROOT	1 [hp_X]  in 1 g
HARPAGOPHYTUM ZEYHERI ROOT (UNII: 1CTB7R80VI) (HARPAGOPHYTUM ZEYHERI ROOT - UNII:1CTB7R80VI)	HARPAGOPHYTUM ZEYHERI ROOT	1 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACRYLAMIDE (UNII: 20R035KLCI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9077-63	1 in 1 BOX	03/17/2022
1		70 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0220-9077-69	1 in 1 BOX	03/17/2022
2		14 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0220-9077-83	1 in 1 BOX	03/28/2023
3		120 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0220-9077-93	5 g in 1 POUCH; Type 0: Not a Combination Product	06/09/2023
5	NDC: 0220-9077-82	1 in 1 BOX	07/17/2023
5		120 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		03/17/2022

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9077)