MINNERVA II- lidocaine, epinephrine gel

Minnerva II by

Drug Labeling and Warnings

Minnerva II by is a Otc medication manufactured, distributed, or labeled by SofTap Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS (per ml) PURPOSE

• Lidocaine USP - 4%

topical anesthetic

• Epinephrine HCl - 0.4%

vasoconstrictor

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

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.

WARNINGS

KEEP OUT OF REACH OF CHILDREN

If swallowed seek medical help or contact Poison Control Center immediately.

USES

• On adults over 18 only
• Temporarily relieves pain due to cuts, scrapes, or abrasions
• 

WARNINGS

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENTS (per ml) PURPOSE

• Lidocaine USP - 4%

topical anesthetic

• Epinephrine HCl - .04%

vasoconstrictor

Minnerva II

INGREDIENTS AND APPEARANCE

MINNERVA II 
lidocaine, epinephrine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82718-2210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE HYDROCHLORIDE	0.004 g  in 10 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.3 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BISULFATE (UNII: BU8V88OWIQ)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)

Product Characteristics
Color	white (Clear Gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82718-2210-1	10 g in 1 TUBE; Type 0: Not a Combination Product	05/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/11/2022

Labeler - SofTap Inc (780568353)

Registrant - SofTap Inc (780568353)