Active Ingredients
Camphor 4.0% w/w
Menthol 10.0% w/w
Relieve And Relax Pain Relieving Gel
FDA Label NDC 81790-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mac Innovations, Llc for the product Relieve And Relax Pain Relieving (NDC 81790-001). 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 active ingredients, purpose, uses:, warnings:, do not use, keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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:
Label (Label)
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