Active Ingredient
Menthol 10.5%
Pain Relief Spray
FDA Label NDC 69396-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Pain Relief (NDC 69396-175). 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, indication, warnings, stop use and ask a doctor, keep out of the reach of children, directions, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Relieving Spray
Indication
Temporary Relief of minor aches and pains of joints and muscles associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For External Use Only
Contents under pressure. Do not puncture or incinerate
Flammable: Keep away from excessive heat or open flame.
Do not store at temperature above 120°F.
Stop Use And Ask A Doctor
- If you experience pain, swelling or blistering of the skin.
- Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
- Arthritic pain persists for more than 10 days or redness is present
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children:
12 years of age and older, spray on to affected area not more than 3 to 4 times daily. Massage not necessary.
Children under 12 years of age: consult a physician
wash hands after use with cool water
When Using This Product
When using this product
- use only as directed
- avoid contact with the eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if ecessive irritation develops
- do not bandage tightly or use with heating pad or device
Other Information
- Store at (20°-25°C) (68°F - 77°F).
- Store in a dry place away from direct sunlight
If Pregnant Or Breast Feeding
Ask a health professional before use.
Inactive Ingredients
Camellia Sinensis leaf extract, centella asiatica extract, Chamomilla recutita (Matricaria) flower extract, Dimethyl sulfone, isopropyl myristate, Glycyrrhiza glabra (licorice) rooth extract, polygonum cuspidatum root extract, Rosmarinus officinais (rosemary) leaf extract, SD alcohol, Scutellaria caicalensis root extract, water.
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 6000
* This product is not manufactured or distributed by RB Health (US), the distributor of BioFreeze.
* Please review the disclaimer below.
