Minnerva II

Manufacturer
SofTap Inc
Effective date
2022-05-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:33

Label at a glance#

ProductMinnerva II
Active ingredientEPINEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (per ml) PURPOSE

  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - 0.4%

vasoconstrictor

FrontLabelFrontLabel

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

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

DO NOT USE

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

InsideLabel1InsideLabel1

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

LabelPage3LabelPage3

WARNINGS

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

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

USES

INDICATIONS & USAGE SECTION

  • On adults over 18 only
  • Temporarily relieves pain due to cuts, scrapes, or abrasions
  • LabelPage1LabelPage1

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

LabelPage4LabelPage4

ACTIVE INGREDIENTS (per ml) PURPOSE

OTC - PURPOSE SECTION

  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - .04%

vasoconstrictor

Minnerva II

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front of TubeFront of Tube

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EPINEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82718-2210-1Minnerva II10 g in 1 TUBEGEL102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82718-2210MINNERVA II (LIDOCAINE, EPINEPHRINE) GEL [SOFTAP INC]2Current NDC, Legacy NDC, 1 package rows20220511_ddd34237-7770-19b3-e053-2995a90af775.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82718-221082718-2210-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minnerva IILIDOCAINE, EPINEPHRINESofTap Incddd34237-7770-19b3-e053-2995a90af7752022-05-05WarningsExact identifier
ndc (package): 82718-2210-1
ndc (product): 82718-2210
ndc11 (package): 82718221001
spl id: de4a096f-33d4-35f1-e053-2a95a90a8ee7
spl set id: ddd34237-7770-19b3-e053-2995a90af775

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.