Minnerva Ii Gel
FDA Label NDC 82718-2210

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Softap Inc for the product Minnerva Ii (NDC 82718-2210). 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 drug facts, other ingredients, do not use, keep out of, directions, warnings, uses, active ingredients (per ml) purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Other Ingredients

→ Do Not Use

→ Keep Out Of

→ Directions

→ Warnings

→ Uses

→ Active Ingredients (per Ml) Purpose

→ Minnerva Ii

Drug Facts

ACTIVE INGREDIENTS (per ml) PURPOSE

Lidocaine USP - 4%

topical anesthetic

Epinephrine HCl - 0.4%

vasoconstrictor

Frontlabel (Minnervalabel 2)

Other Ingredients

Deionized water, glycerin, sodium bisulphate, sodium metabisulfate, dehydroxanthan gum, chlorobutanol, sodium chloride

Do Not Use

With occlusion
If you have a known allergy or sensitivity to any ingredients.
If pregnant or breastfeeding
On large areas of the body
In large quantities. Apply only 1-2ml to desired area
If you have a history of liver disease or impairment
If safety seal is broken before first use

Keep Out Of

The eye and mouth. If accidental contact occurs, you may feel burning or stinging. Wash with water or eyewash immediately. If your eyes have pain, blurry vision, extreme sensitivity to light, or a feeling of sand in the eye, contact an eye care physician immediately.

WHEN USING THIS PRODUCT

You may not feel pain. Avoid sources of heat or injury.
You may have temporary rash, redness, swelling, or itching
Contact your physician promptly if you notice any unusual effects such as dizziness or drowsiness, difficulty breathing, trembling, chest pain, or irregular heartbeat.

Made in the USA for SofTap

550 N Canyons Pkwy

Livermore, CA 94551

www.softaps.com

Insidelabel1 (Minnervalabel 3)

Directions

For external use only. Prior to application, a sensitivity test is advised. Before applying, cleanse the skin with an alcohol-free or acetone-free cleanser. Apply 1-2 cc to the desired area for up to 6 times per day. Discontinue use if allergic reaction occurs. Store in a cool dark place (up to 80 degrees F) or refrigerate.