Active Ingredients
Lidocaine USP 4%
Pomg Pain Relief Body Cream
FDA Label NDC 84615-006
12 label sections · Submitted to the FDA by Pomg Llc · 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 Body (NDC 84615-006). 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 USP 4%................Topical Anesthetic
Use
- For temporary relief of pain in muscles, joints, and tendons
- Can also be used for minor burns and bug bites
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
• Avoid contact with eyes and other mucous membranes
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 with 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
• If using on hands, avoid contact with eyes and mouth
Inactive Ingredients
organic shea butter, organic aloe vera juice, organic mango butter, organic beeswax, organic cocoa butter (unscented), emu oil, organic grapeseed oil, organic sweet almond oil,* organic jojoba oil, organic apricot kernel oil,* organic avocado oil, organic hempseed oil, organic rosehip oil, organic argan oil.*
*Allergy Information: This product contains tree nuts (almond, argan, and apricot kernel)
Package Label.Principal Display Panel
NDC: 84615-006-05
Lidocaine 4%
P.O.M.G.
Pharmaceutical Organic Medicine Group
Pain Relief
Body Cream
Organic
Maximum Strength Lidocaine Without a Prescription
Refreshes and Rejuvinates All Skin Types
5 oz (148 mL)
* Please review the disclaimer below.
