SPL v2
SPL
SPL Set ID de3af3fa-8acf-2379-e053-2995a90ac77d
Route
TOPICAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracaine (0.02 g) Lidocaine (0.03 g)
Inactive Ingredients
Water Phenoxyethanol Fd&c Blue No. 1 Methylparaben Fd&c Green No. 3 Fd&c Yellow No. 5 Sodium Carbonate Medium-chain Triglycerides Glycerin Petrolatum Stearic Acid Stearyl Alcohol Butylated Hydroxytoluene Almond Oil Propylparaben Safflower Oil Shea Butter .alpha.-tocopherol Acetate Glyceryl Stearate Se Polysorbate 60 Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-05-06

Description

ACTIVE INGREDIENTS (per ml) PURPOSE Lidocaine USP - 3% topical anesthetic Tetracaine USP - 2% topical anesthetic

Purpose

Lidocaine USP - 3% topical anesthetic Tetracaine USP - 2% topical anesthetic


Medication Information

Purpose
  • Lidocaine USP - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

Description

ACTIVE INGREDIENTS (per ml) PURPOSE Lidocaine USP - 3% topical anesthetic Tetracaine USP - 2% topical anesthetic

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

TOPICAL ANESTHETIC PHASE I

10 gms

Warnings

KEEP OUT OF REACH OF CHILDREN

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 - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

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

Other Ingredients

Deionized water, caprylc/capric triglyceride,stearic acid, glycerin, glyceryl stearate, petrolatum, safflower oil, shea butter, polysorbate 60, stearyl alcohol, sweet almond oil, tocopheryl acetate, bht, propylene glycol, sodium carbonate, phenoxyethanol, methylparaben, polyparaben. May contain: FD&C Green #3, FD&C Yellow #5, FD&C Blue #1


Structured Label Content

Uses (USES)
  • On adults over 18 only
  • Temporarily relieves pain due to cuts, scrapes, or abrasions
Purpose (PURPOSE)
  • Lidocaine USP - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

Blockaid (BLOCKAID)

TOPICAL ANESTHETIC PHASE I

10 gms

Warnings (WARNINGS)

KEEP OUT OF REACH OF CHILDREN

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 - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

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

Other Ingredients (OTHER INGREDIENTS)

Deionized water, caprylc/capric triglyceride,stearic acid, glycerin, glyceryl stearate, petrolatum, safflower oil, shea butter, polysorbate 60, stearyl alcohol, sweet almond oil, tocopheryl acetate, bht, propylene glycol, sodium carbonate, phenoxyethanol, methylparaben, polyparaben. May contain: FD&C Green #3, FD&C Yellow #5, FD&C Blue #1


Advanced Ingredient Data


Raw Label Data

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