FDA Label for Minnerva Ii
View Indications, Usage & Precautions
Minnerva Ii Product Label
The following document was submitted to the FDA by the labeler of this product Softap Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
ACTIVE INGREDIENTS (per ml) PURPOSE
- Lidocaine USP - 4%
- Epinephrine HCl - 0.4%
topical anesthetic
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.
- 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.
WHEN USING THIS PRODUCT
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.
KEEP OUT OF REACH OF CHILDREN
Uses
- On adults over 18 only
- Temporarily relieves pain due to cuts, scrapes, or abrasions
Active Ingredients (Per Ml) Purpose
- Lidocaine USP - 4%
- Epinephrine HCl - .04%
topical anesthetic
vasoconstrictor
Minnerva Ii
* Please review the disclaimer below.