Label: MINNERVA II- lidocaine, epinephrine gel
- NDC Code(s): 82718-2210-1
- Packager: SofTap Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated May 5, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- OTHER INGREDIENTS
- DO NOT USE
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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
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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
- USES
- WARNINGS
- ACTIVE INGREDIENTS (per ml) PURPOSE
- Minnerva II
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INGREDIENTS AND APPEARANCE
MINNERVA II
lidocaine, epinephrine gelProduct 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)
