Arnica gel
Arnica gel is an FDA drug label for the active ingredient ARNICA manufactured by WALGREENS administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210715.
- Generic name
- ARNICA
- Manufacturer
- WALGREENS
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0363-0139
- Application
- N/A
- Label effective
- 20210715
About this product
Arnica gel is an FDA-registered drug product whose active ingredient is ARNICA. It is labelled by WALGREENS taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0363-0139, label effective 20210715. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing ARNICA are most often described in connection with: temporarily relieves, muscel pain, stiffness due, minor injuries, falls reduces. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses* temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls reduces pain, swelling and discoloration from bruises
Dosage & Administration
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.
Warnings
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.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0535-2016 | 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Walgreens Infusion Services | Class II | Terminated | 20160106 |
| D-0533-2016 | Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack | Walgreens Infusion Services | Class II | Terminated | 20160106 |
| D-0526-2016 | Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Walgreens Infusion Services | Class II | Terminated | 20160106 |
| D-0557-2016 | 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Walgreens Infusion Services | Class II | Terminated | 20160106 |
| D-0537-2016 | Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Walgreens Infusion Services | Class II | Terminated | 20160106 |
Frequently asked questions
What is Arnica gel used for?
Uses* temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls reduces pain, swelling and discoloration from bruises
Who makes Arnica gel?
WALGREENS is the labeler of record for Arnica gel.
What form does Arnica gel come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Arnica gel prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Arnica gel been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.