Otc - Active Ingredient
Arnica montana 1X HPUS 7%
Arnica Montana Gel
FDA Label NDC 0363-5150
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 Co. for the product Arnica Montana (NDC 0363-5150). 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 otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
alcohol, carbomer, purified water, sodium hydroxide
Dosage & 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.
Indications & Usage
temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls, reduces pain, swelling and discoloration from bruises
Warnings
For external use only
When using this product avoid contact with eyes, mucous membranes, damaged skin, or wounds.
Do not use if you are allergic to Arnica montana or to any of this 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 - 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.
Otc - Purpose
Trauma, muscle pain, and stiffness, swelling from injuries, discoloration from bruising
Other Safety 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).
Package Label.Principal Display Panel
Ct515026 (Ct515026)
Lb515026 (Arnicapainrelievinggel Tube)
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