Arnicare Bruise Gel
FDA Label NDC 0220-9084

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Arnicare Bruise (NDC 0220-9084). 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, uses, for external use only, do not use if, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Arnica montana 1X

Purpose

Arnica montana 1X - Reduces pain, swelling and discoloration from bruising

Uses

Reduces pain, swelling and discoloration from bruises.

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 this product's inactive ingredients.

When Using This Product

  • use only as directed
  • do not banadage tightly or use a heating pad

Stop Use And Ask A Doctor If

condition persists for more than 3 days or worsens.

Otc - Pregnancy Or Breast Feeding


If Swallowed,

get medical help or contact Poison Control Center right away.

Directions

Apply a thin layer of Arnicare Bruise to affected area and massage gently as soon as possible after or minor bruise. Repeat 3 times a day or as needed.

Other Information

  • do not use if glued carton end flaps are open or if the tube seal is broken

Inactive Ingredients

Alcohol, carbomer, purified water, sodium hydroxide

Questions, Comments?

www.Arnicare.com
www.BoironUSA.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA 19073-3267

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