SPL v2
SPL
SPL Set ID ddd34237-7770-19b3-e053-2995a90af775
Route
TOPICAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (0.004 g) Lidocaine (0.3 g)
Inactive Ingredients
Sodium Metabisulfite Chlorobutanol Sodium Chloride Glycerin Water Sodium Bisulfate Dehydroxanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-05-11

Description

ACTIVE INGREDIENTS (per ml) PURPOSE Lidocaine USP - 4% topical anesthetic Epinephrine HCl - 0.4% vasoconstrictor

Purpose

Lidocaine USP - 4% topical anesthetic Epinephrine HCl - .04% vasoconstrictor


Medication Information

Purpose

Lidocaine USP - 4% topical anesthetic Epinephrine HCl - .04% vasoconstrictor

Description

ACTIVE INGREDIENTS (per ml) PURPOSE Lidocaine USP - 4% topical anesthetic Epinephrine HCl - 0.4% vasoconstrictor

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

KEEP OUT OF REACH OF CHILDREN

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

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.

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
Drug Facts

ACTIVE INGREDIENTS (per ml) PURPOSE

  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - 0.4%

vasoconstrictor

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

Minnerva Ii

Other Ingredients
  • Deionized water, glycerin, sodium bisulphate, sodium metabisulfate, dehydroxanthan gum, chlorobutanol, sodium chloride
Active Ingredients (per Ml) Purpose
  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - .04%

vasoconstrictor


Structured Label Content

Uses (USES)
  • On adults over 18 only
  • Temporarily relieves pain due to cuts, scrapes, or abrasions
Warnings (WARNINGS)

KEEP OUT OF REACH OF CHILDREN

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

Directions (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.

Do Not Use (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
Drug Facts (DRUG FACTS)

ACTIVE INGREDIENTS (per ml) PURPOSE

  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - 0.4%

vasoconstrictor

Keep Out Of (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

Minnerva Ii (Minnerva II)

Other Ingredients (OTHER INGREDIENTS)
  • Deionized water, glycerin, sodium bisulphate, sodium metabisulfate, dehydroxanthan gum, chlorobutanol, sodium chloride
Active Ingredients (per Ml) Purpose (ACTIVE INGREDIENTS (per ml) PURPOSE)
  • Lidocaine USP - 4%

topical anesthetic

  • Epinephrine HCl - .04%

vasoconstrictor


Advanced Ingredient Data


Raw Label Data

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