Active Ingredient
| Active Ingredient | Use |
| Menthol 3.5% | Topical Analgesic |
Painzone Light
FDA Label NDC 70338-651
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 Light (NDC 70338-651). 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, uses, do not use, stop use and ask a physicinan if:, directions, storage, inactive ingredient, warnings for external use only:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Uses:
- For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains
Do Not Use
Do not use:
- On wounds or damaged skin
- With a heating pad
- On children under 12 years of age
- If pregnant or breast feeding
Stop Use And Ask A Physicinan If:
Stop use and ask a physician if:
- Conditiion worsens or symtops persist for more than 7 days
- Symptoms clear up and occur again within a few days
- Excessive skin irritation occurs
Directions
Directions
Use only as directed
Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
Children under 12 years of age consult a physician
Wash hands after applying
Storage
Store at 68-86 degrees with lid tightly closed
Inactive Ingredient
Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water
Warnings For External Use Only:
Warnings For External Use Only:
- Avoid contact with eyes and mucous membranes. Do not bandage tightly
Distributed By
Distributed by: MedZone
Lenexa, Kansas
Ph 913-948-9663
www.medzonecorp.com
* Please review the disclaimer below.
