Drugplain

ARNICA MONTANA 3 [hp_X]/mL

ARNICA MONTANA · LIQUID · Rxhomeo Private Limited d.b.a. Rxhomeo, Inc

2 Recalls on Record
Plain English

Arnica Montana is an herbal remedy taken by mouth that some people use to help with bruising and minor muscle soreness. This product is available over-the-counter without a prescription.

Key Facts

Brand Name
ARNICA MONTANA
Generic Name
ARNICA MONTANA
NDC Code (Product)
15631-2600
Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Strength
3 [hp_X]/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Marketing Start
03/19/2024

Recall History

2 Recalls on Record
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia12 reports
fatigue11 reports
headache10 reports
drug hypersensitivity9 reports
pruritus9 reports
back pain7 reports
muscular weakness7 reports
pain7 reports
balance disorder6 reports
cardiac disorder6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: Temporarily relieves pain, swelling, and discoloration associated with: Bruises Minor falls Sports injuries Muscle soreness

Dosage & Administration

Directions: Apply a thin layer to the affected area 2 to 3 times daily. Gently massage until absorbed. Use as soon as possible after minor injury.

Warnings

For external use only Do not apply to broken skin or open wounds. Avoid contact with eyes. When using this product Avoid contact with eyes. Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding Ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is ARNICA MONTANA used for?

Arnica Montana is an herbal remedy taken by mouth that some people use to help with bruising and minor muscle soreness. This product is available over-the-counter without a prescription.

Is ARNICA MONTANA a controlled substance?

ARNICA MONTANA is not classified as a controlled substance by the DEA.

What is the generic name for ARNICA MONTANA?

The generic name for ARNICA MONTANA is ARNICA MONTANA. There are 11 other brand versions of ARNICA MONTANA.

What is the NDC code for ARNICA MONTANA 3 [hp_X]/mL?

The NDC (National Drug Code) for ARNICA MONTANA 3 [hp_X]/mL is 15631-2600, listed by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc.

Product NDC

15631-2600

Package NDC

15631-2600-0

Other ARNICA MONTANA Dosages

Other Arnica Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)