Active Ingredient:
Arnica Montana 1X (HPUS) 7%
Brazmedics Arnica Cream
FDA Label NDC 61727-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Homeocare Laboratories for the product Brazmedics Arnica Cream (NDC 61727-114). 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 ingredient:, purpose, keep out of the reach of children, warnings:, inactive ingredients:, directions:, brazmedics arnica front label, brazmedics arnica cream back label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
#1 First-aid Remedy for the relief of Bruises, Injuries, Muscle Aches, Pre/Post Surgery, Pain Relief
Homeopathic Medicine
PARABENS FREE
Keep Out Of The Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings:
For external use only. Ask a doctor before use if pregnant or breastfeeding. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients:
Avocado Oil, Caprylyl Glycol, Cetyl Alcohol, Dimethicone, Dimethyl Taurate Copolymer, Glycerin USP, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hexylen Glycol, Phenoxyethanol, Polyethylene, Sodium Polyacrylate, Potassium Sorbate, Purified water, Sodium Acrylate/Sodium Acryloyl, Sunflower Oil
Directions:
For external use only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 year old (under 2 years ask a doctor).
When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a doctor if: Condition worsens, symptoms last more than 7 days, you are allergic to any of the ingredients.
For external use only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a doctor).
* Please review the disclaimer below.
