ARNICARE ARTHRITIS
Arnicare Arthritis Cream
da6c81e6-2c76-56de-e053-2a95a90a0397
HUMAN OTC DRUG LABEL
May 12, 2025
Boiron
DUNS: 282560473
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ARNICA MONTANA, HARPAGOPHYTUM PROCUMBENS ROOT, HARPAGOPHYTUM ZEYHERI ROOT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves minor joint and muscle pain and stiffness due to:
arthritis
minor injuries
overexertion
falls
repetitive motions
OTC - ACTIVE INGREDIENT SECTION
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.
OTC - PURPOSE SECTION
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
WARNINGS SECTION
For external use only.
OTC - DO NOT USE SECTION
- if you are allergic to Arnica montana, Harpagophytum or to any of this product's inactive ingredients
- with other topical products for pain
OTC - WHEN USING SECTION
- 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
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
**If pregnant or breast-feeding,**ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
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.
INACTIVE INGREDIENT SECTION
acrylamide/sodium acryloyldimethyltaurate copolymer , alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sorbitan oleate, sweet almond oil
OTC - QUESTIONS SECTION
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