MINNERVA II- lidocaine, epinephrine gel 
SofTap Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DRUG FACTS

ACTIVE INGREDIENTS (per ml) PURPOSE

topical anesthetic

vasoconstrictor

FrontLabel

OTHER INGREDIENTS

DO NOT USE

KEEP OUT OF

WHEN USING THIS PRODUCT

Made in the USA for SofTap

550 N Canyons Pkwy

Livermore, CA 94551

www.softaps.com

InsideLabel1

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.

LabelPage3

WARNINGS

KEEP OUT OF REACH OF CHILDREN

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

USES

WARNINGS

KEEP OUT OF REACH OF CHILDREN

LabelPage4

ACTIVE INGREDIENTS (per ml) PURPOSE

topical anesthetic

vasoconstrictor

Minnerva II

Front of Tube

MINNERVA II 
lidocaine, epinephrine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82718-2210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE0.004 g  in 10 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.3 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Clear Gel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82718-2210-110 g in 1 TUBE; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/11/2022
Labeler - SofTap Inc (780568353)
Registrant - SofTap Inc (780568353)

Revised: 5/2022
Document Id: de4a096f-33d4-35f1-e053-2a95a90a8ee7
Set id: ddd34237-7770-19b3-e053-2995a90af775
Version: 2
Effective Time: 20220505
 
SofTap Inc