FDA Label for Relieve And Relax Pain Relieving

View Indications, Usage & Precautions

Relieve And Relax Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Mac Innovations, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Camphor 4.0% w/w

Menthol 10.0% w/w


Purpose



Topical Analgesic


Uses:



Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.


Warnings:



• For external use only.

• Flammable, Keep away from fire or flame.

• Avoid getting into eyes or on mucous membranes.

• If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.


Do Not Use



• on wounds or damaged skin.

• Do not bandage tightly.
• Caution: Discontinue use if excessive irritation of the skin develops.


Keep Out Of Reach Of Children.



• Use only as directed.
• Do not use if pregnant or breastfeeding.
• If swallowed, get medical help or contact a poison control center right away.


Directions:



SHAKE WELL BEFORE USE
Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.


Other Information:



Store between 10 and 30°C (50-86°F) Avoid freezing and excessive heat above 32°C (90°F)


Inactive Ingredients:



Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water


Questions Or Comments?



Call Toll Free: 954-747-3300
Monday through Friday 8:30 AM to 5:00 PM EST.
Visit us: www.RelieveAndRelax.com
email us: [email protected]
Or Write us: MAC Innovations, LLC
Attn: Quality Assurance Dept.
2301 SW 145th Ave.
Miramar, FL USA 33027


Package Labeling:




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