Otc - Active Ingredient
Active ingredients
Arnica mont 1X (HPUS)
Camphora 8X (HPUS)
Cinnamomum 1X (HPUS)
Mantholum 1X (HPUS)
Syz. Aroma 1X (EHPI)
Bm Arnica Ointment
FDA Label NDC 85816-6029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bm Private Limited for the product Bm Arnica (NDC 85816-6029). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredients Purpose*
Arnica mont 1X (HPUS)............pain
Camphora 8X (HPUS)..............muscle soreness
Cinnamomum 1X (HPUS)........poor circulation
Mantholum 1X (HPUS).............pain and swelling
Syz. Aroma 1X (EHPI)............localized nerve pain
Indications & Usage
Uses*
Helps temporarily relieve: minor aches; occasional muscle and joint aches; stiffness; swelling; discomfort; soreness
Warnings
Warnings:
For external use only.
Avoid contact with eyes and mucous membranes.
Keep out of reach of children.
If you have severe symptoms, consult a doctor before use.
Do not use on broken or damaged skin.
Otc - Keep Out Of Reach Of Children
Warnings:
Keep out of reach of children.
Dosage & Administration
Directions:
Use as directed.
Clean the affected area before application.
Apply a thin layer to the affected area, 2-3 times daily or as directed by a physician.
Storage And Handling
Storage:
Store in a cool, dry place below 30°C (86°F).
Protect from direct sunlight.
Inactive Ingredient
Inactive Ingredients:
Cetostearyl alcohol, Paraffin oil, White soft paraffin
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