Active Ingredient
Arnica montana
1X HPUS 7%
Arnica Gel
FDA Label NDC 0363-0139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Arnica Gel (NDC 0363-0139). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, dosage and administration, uses*, warnings, keep out of reach of children, otc - purpose, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Alcohol, Carbomer, Purified water, Sodium Hydroxide
Dosage And Administration
Apply a thin layer of gel to affected area and massage gently as soon as possible after minor injury. Repeat 3 times a day or as needed.
Uses*
- temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls
- reduces pain, swelling and discoloration from bruises
Warnings
For external use only. Avoid contact with eyes, mucous membranes, damaged skin, or wounds.
Do not use if you are allergic to Arnica montana or to any of thus product's inactive ingredients.
When using this product
- use only as directed
- do not bandage tightly or use a heating pad.
Stop use and ask a doctor if condition persists for more than 3 days or worsens.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Trauma, muscle pain, and, stiffness, swelling from injuries, discoloration from bruising
Other Information
- Do not use if glued carton end flaps are open or if the tube seal is broken,
- Store at 68-77 F (20-25 C)
Questions Or Comments?
1-800-925-4733
Package Label.Principal Display Panel
Carton (Carton Arnica Listing)
* Please review the disclaimer below.
