FDA.reportPublic FDA data

Tetragel Punch Topical Analgesic Gel

Manufacturer
Unit Dose, Ltd.
Effective date
2017-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:05:52

Label at a glance#

ProductTetragel Punch Topical Analgesic
Active ingredientTETRACAINE
Label structure7 sections

Indications and uses

​External Use only Broken ​Skin. Temporarily relieves local discomfort or pain  ​from minor cuts, scrapes or abrasions.

Dosage and administration

Dab 1-2 gram to affected area as needed for telief. May repeat as needed up to four times per day. Use eyewash if accidental direct contact with eyes. Discontinue use if you have any undesired effect such as rash or irritation of treated area.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

​Tetracaine 2% w/w

Purpose

OTC - PURPOSE SECTION

​External Local Anesthetic

Uses:

INDICATIONS & USAGE SECTION

​External Use only Broken ​Skin. Temporarily relieves local discomfort or pain  ​from minor cuts, scrapes or abrasions.

Warnings

WARNINGS SECTION

Do not use if you have

OTC - DO NOT USE SECTION

  • A know allergy or sensitivity to any of the ingredients.
  • Have a history of severe liver disease or impairment

When using this product

OTC - WHEN USING SECTION

  • You may not have pain - Avoid sources of heat or injury
  • You may have burning or stinging if accidental eye contact
  • You mat have temporary skin irritation or sensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of eyes and mouth. Keep out of reach of children.

Do not use if pregnant or breast feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If accidentally swallowed get medical help right away. Not for chronic use.

Directions

DOSAGE & ADMINISTRATION SECTION

Dab 1-2 gram to affected area as needed for telief. May repeat as needed up to four times per day. Use eyewash if accidental direct contact with eyes. Discontinue use if you have any undesired effect such as rash or irritation of treated area.

Other Information

SPL UNCLASSIFIED SECTION

Store in a cool dark place or refrigerate.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

DI Water, USP Glycerin, Methylcellulose

Preservatives: Chlorobutanol, Sodium Bisulfite, Sodium EDTA

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterOuter

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67194-01367194-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CHLOROBUTANOLHM4YQM8WRCIACT
SODIUM BISULFITETZX5469Z6IIACT
EDETATE SODIUMMP1J8420LUIACT
TETRACAINE0619F35CGVACTIB

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
60e29ef6-0b0a-559a-e053-2a91aa0a5cb06e0cd3a0-6b4d-4469-bb18-083cb1d7887a2017-12-21WarningsExact identifier
spl id: 60e29ef6-0b0a-559a-e053-2a91aa0a5cb0
spl set id: 6e0cd3a0-6b4d-4469-bb18-083cb1d7887a

Reported adverse events (FAERS/openFDA)#

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