Active Ingredients:
Arnica montana 7%
Arnica Gel
FDA Label NDC 81417-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sled Distribution, Llc for the product Arnica Gel (NDC 81417-005). 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 ingredients:, purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.
Indications & Usage
Uses Temporarily relieves muscle pain and stiffness due to:
- minor injuries
- overexertion
- falls
- reduces symptoms of bruising such as : discoloration, pain, swelling.
Warnings
WarningsFor external use only.
Otc - Do Not Use
Do not use if you are allergic to Arnica montana or any of this product's inactive ingredients.
Otc - When Using
When using this product
- avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
- dryness or irritation may occur
- use only as directed
- 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
Stop use and ask a doctor if
- Conditions persist for more than 3 days or worsens
- Symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.
Other Safety Information
Other information do not use if the sachet seal is broken.
Inactive Ingredient
Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide
Package Label.Principal Display Panel
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