FDA.reportPublic FDA data

Blockaid

Manufacturer
SofTap Inc
Effective date
2022-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:29

Label at a glance#

ProductBlockaid
Active ingredientTETRACAINE, LIDOCAINE
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (per ml) PURPOSE

  • Lidocaine USP - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

LabelPage1LabelPage1

PURPOSE

OTC - PURPOSE SECTION

  • Lidocaine USP - 3%

topical anesthetic

  • Tetracaine USP - 2%

topical anesthetic

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

DO NOT USE

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

LabelPage2LabelPage2

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

LabelPage3LabelPage3

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

WARNINGS

WARNINGS SECTION

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

BLOCKAID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPICAL ANESTHETIC PHASE I

10 gms

LabelFrontLabelFront

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TETRACAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82718-1110-1Blockaid10 g in 1 TUBECREAM102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82718-1110BLOCKAID (LIDOCAINE, TETRACAINE) CREAM [SOFTAP INC]2Current NDC, Legacy NDC, 1 package rows20220507_de3af3fa-8acf-2379-e053-2995a90ac77d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82718-111082718-1110-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
METHYLPARABENA2I8C7HI9TIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM CARBONATE45P3261C7TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
TETRACAINE0619F35CGVACTIB
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LIDOCAINE98PI200987ACTIB
ALMOND OIL66YXD4DKO9IACT
PROPYLPARABENZ8IX2SC1OHIACT
SAFFLOWER OIL65UEH262ISIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BlockaidLIDOCAINE, TETRACAINESofTap Incde3af3fa-8acf-2379-e053-2995a90ac77d2022-05-06WarningsExact identifier
ndc (package): 82718-1110-1
ndc (product): 82718-1110
ndc11 (package): 82718111001
spl id: de4b93cc-1f65-1a4a-e053-2995a90a48a5
spl set id: de3af3fa-8acf-2379-e053-2995a90ac77d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.