Otc - Active Ingredient
Active Ingredients for Healing Gels:
Arnica Montana 50M
Hypericum Perforatum 50M
Ledum Palustre 50M
Rhus toxicodendron 50M
Ruta graveolens 50M
Activmend Pro Patch
FDA Label NDC 76277-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cearna, Inc. for the product Activmend Pro (NDC 76277-123). 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, purpose, uses, warnings, otc - do not use, stop use and ask a doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose:
Arnica Montana 50M...........................Bruising, muscle strain
Hypericum Perforatum 50M................Pain
Ledum Palustre 50M...........................Swelling, pain
Rhus toxicodendron 50M....................Sprains, strains, swelling, pain
Ruta graveolens 50M..........................Strains
Uses
For the reduction of swelling and pain associated with joint sprains, muscle strains, shin splints, dislocations, overuse injuries, and bruising.
Warnings
Warnings
For external use on intact skin only
- Use only as directed.
- Do not bandage tightly.
- Stop use and ask a doctor if condition worsens.
- Do not use in the eyes, over open wounds, or if you have unexpected bleeding.
- If pregnant or breast-feeding, ask a health professional before use.
- Do not use if you are allergic to any of this product's active or ingredients.
Otc - Do Not Use
Do not use:
Do not use in the eyes, over open wounds, or if you have unexpected bleeding
Stop Use And Ask A Doctor
​Stop use and ask a doctor if condition worsens
Otc - Pregnancy Or Breast Feeding
I f pregnant or breast-feeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Directions:
Adults and Children 12 years of age and over
- Clean and dry affected area.
- Remove patch from film.
- Place healing pads on intact skin.
- Wear one activMend patch up to 24 hours.
Children under 12 years of age - Consult a doctor
Storage And Handling
Other information
Store at room temperature.
Do not freeze.
Tightly reseal pouch containing unused patches.
Inactive Ingredients
Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water
Questions?
Other
The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.
Do not use if pouches are open or damaged.
Package Label.Principal Display Panel
* Please review the disclaimer below.
