Drug Facts
ACTIVE INGREDIENTS (per ml) PURPOSE
- Lidocaine USP - 3%
- Tetracaine USP - 2%
topical anesthetic
topical anesthetic
Labelpage1 (Blockaidlabel 2)
Blockaid Cream
FDA Label NDC 82718-1110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softap Inc for the product Blockaid (NDC 82718-1110). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, other ingredients, uses, do not use, keep out of, directions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- Lidocaine USP - 3%
- Tetracaine USP - 2%
topical anesthetic
topical anesthetic
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
Uses
- On adults over 18 only
- Temporarily relieves pain due to cuts, scrapes, or abrasions
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.
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
Labelpage2 (Blockaidlabel 3)
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.
Labelpage3 (Blockaidlabel 4)
Warnings
KEEP OUT OF REACH OF CHILDREN
If swallowed seek medical help or contact a Poison Control Center immediately
Blockaid
TOPICAL ANESTHETIC PHASE I
10 gms
Labelfront (Blockaidlabel 1)
* Please review the disclaimer below.
