Active Ingredients
Lidocaine HCl 4%
Menthol 5%
Pomg Pain Relief Roller Gel
FDA Label NDC 84615-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pomg Llc for the product Pomg Pain Relief Roller (NDC 84615-004). 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, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lidocaine HCl 4% ……….…Topical Anesthetic
Menthol 5% ………………... Pain Relief
Use
- For temporary relief of pain in muscles, joints, and tendons
Warnings
For external use only
Otc - Do Not Use
Do not use
• If you are allergic to any ingredients in this product
• On open sores and wounds
• In large quantities
Otc - When Using
When using this product
• Use only as directed
• Do not bandage tightly
• Avoid contact with eyes and other mucous membranes
• Do not expose the area to external heat or direct sunlight
Otc - Stop Use
Stop use and consult a doctor if
• Conditions worsen or symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days
• Redness is present or excessive skin irritation occurs
• You experience severe burning pain, swelling, or blistering where product was applied
• Allergic reaction occurs
Otc - Pregnancy Or Breast Feeding
• If pregnant or breast-feeding, consult a doctor before use
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away
Directions
• Adults and children 12 years of age and older:
rub a thin film over desired area not more than 3 to 4 times daily
• Children under 12 years of age: consult a doctor
• Wash hands after use with soap and water
Inactive Ingredient
reverse osmosis water, organic aloe juice, magnesium chloride flakes, msm (methylsulfonylmethane), hydroxypropyl starch phosphate, organic arnica (co2 extract), organic calendula (co2 extract), organic capsicum (co2 extract)
Package Label.Principal Display Panel
Menthol 5% Lidocaine 4%
P.O.M.G
Pharmaceutical Organic Medicine Group
Pain Relief Roller
Maximum Strength Lidocaine
Without a Prescription
Made with Organic Ingredients
Quick Drying
Instantly Relieves Pain
Net Wt. 3 OZ (90mL)
* Please review the disclaimer below.
