Active Ingredients
Lidocaine HCL 4.0% w/w
Derma Numb Pain Relief Gel
FDA Label NDC 70188-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A.t.s. Laboratories, Llc for the product Derma Numb Pain Relief (NDC 70188-005). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For temporary relief of pain and itching associated with minor cuts or minor skin irritations.
Warnings
For external use only
Avoid contact with eyes
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas
Otc - Stop Use
Stop use and ask doctor if
• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days. Discontinue use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
• If product is swallowed, get medical help or contact a poison control center right away.
Directions
For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Inactive Ingredients
Achillea Millegolium (Yarrow) Extract, Caprylyl Glycol, Citric Acid, Disodium EDTA, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Sodium Metabisulfate, Water.
Other Information
Protect this product from excessive heat and direct sun.
Questions Or Comments?
954-492-9898
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