Otc - Purpose
Topical Analgesic
Relaxium Spray
FDA Label NDC 84742-001
10 label sections · Submitted to the FDA by American Behavioral Research Institute · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Behavioral Research Institute for the product Relaxium (NDC 84742-001). 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 - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains.
Warnings
For external use only.
Otc - When Using
When using this product• avoid any contact with the eyes or mucous
membranes • flush with cold water if accidentally sprayed in eyes • do not apply
to wounds or damaged skin • do not apply to irritated skin • do not bandage •
wash hands after use with cool water • do not use with heating pad or device •
contents under pressure • do not puncture or incinerate • do not use if you are
allergic to any ingredient in Flexium • do not store at temperature above 120° F
Otc - Stop Use
Stop use and ask doctor if• condition worsens, or if symptoms persist for
more than 7 days, or clear up and reoccur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children• If swallowed, get medical help or contact a Poison Control Center immediately
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Dosage & Administration
Directions• For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily
Inactive Ingredient
Inactive ingredientsAlcohol Denat., Arnica Montana Flower Extract, Calendula
Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract,
CurcuTame™ Blend [Tamarind (Tamarindus Indica) Extract (Seed), Turmeric (Curcuma Longa)
Extract (Rhizome), Glucosamine Sulfate, Boron Citrate, Hyaluronic Acid, Chondroitin Sulfate,
Boswellia Serrata Extract (Gum Resin), Marine Type II Collagen (from Salmon)],
Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf
Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water
Otc - Questions
Question? 888-353-1205
* Please review the disclaimer below.
