Active Ingredients
Camphor 3%
Menthol 12%
Methyl Salicylate 20%
Painzone
FDA Label NDC 70338-641
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medzone Products Llc for the product Painzone (NDC 70338-641). 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, when using this product, stop use and ask a physician if, do not, 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
Analgesic
Counterirritant
Counterirritant
Uses
Temporarily relieves minor aches and pains of muscle and joints associated with strains, sprains, arthritis, simple backache.
Provides pentrating pain relief.
Warnings
For external use only.
When Using This Product
- do not get into eyes
Stop Use And Ask A Physician If
- Allergic reaction occurs
- Condition worsens or does not improve within 7 days
- Symptoms clear up and return within a few days
- Redness, irritation, swelling, pain or other symptoms begin or increase
Do Not
- Use in or near the eyes
- Use in large quantities, particularly over raw surfaces or blistered areas
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Other Information
Store at room temperature. Avoid excessive heat or cold.
Inactive Ingredients
Aloe Vera Leaf, Glycerin, Jojoba Oil, Oleic Acid, Polyethylene Glycol 400, Silica, Tea Tree Oil
Questions?
Toll-Free 866-MEDZONE (866-633-9663)
www.medzonecorp.com [email protected]
How Supplied
Distributed by MedZone Products LLC
Lenexa, Kansas 66215 All Rights Reserved
* Please review the disclaimer below.
