Dermanumb Analgesic Gel
FDA Label NDC 70188-006

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 Dermanumb Analgesic (NDC 70188-006). 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, 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

Active Ingredients

Lidocaine HCL 4.0% w/w

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, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

Other Information

Protect this product from excessive heat and direct sun.

Questions Or Comments?

954-492-9898

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