FDA.reportPublic FDA data

Tetri-AG

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:51:29

Label at a glance#

ProductTetri-AG
Active ingredientTETRACAINE
Label structure8 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient   Purpose

OTC - ACTIVE INGREDIENT SECTION

Tetracaine 1.9%.       Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of: Pain, associated with

  • Minor burns 
  • Minor cuts 
  • Scrapes 
  • Sunburn

Warnings

WARNINGS SECTION

For external use only.

Do not use

  • in large quantities 
  • over raw surfaces 
  • blistered areas 
  • on wounds or damaged skin 
  • with a heating pad 
  • if you are allergic to any ingredients of this product

When using this product

  • use only as directed 
  • avoid contact with the eyes, mucous membranes or rashes 
  • do not bandage tightly

Stop use and ask a doctor if:

  • symptoms persist for more than 7 days 
  • symptoms clear up and occur again within a few days 
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering 
  • conditions worsen

If pregnant or breast feeding, ask health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (-1800-222-1222) right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.


Children under 2 years of age:

  • do not use, consult a doctor.

Other Information:

SPL UNCLASSIFIED SECTION

Store at 20-25 C (68-77F). [see USP Controlled Room Temperature].

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Methylisothiazolinone, PEG-8, PEG-8 Stearate, PEG-100 Stearate, Polyethylene Glycol

Questions or comments?

SPL UNCLASSIFIED SECTION

Call 1-888-811-2634

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-7120-3GM - Gram83035-7120a4714a45-fcac-4415-bae6-f950d72c34bd12024-04-05

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-712083035-7120-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PEG-8 STEARATE2P9L47VI5EIACT
PEG-100 STEARATEYD01N1999RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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
2516c364-b6e4-de9f-e063-6394a90a3fb547f3804a-c7fc-4a12-a15c-981bcab9e1202024-10-22WarningsExact identifier
spl id: 2516c364-b6e4-de9f-e063-6394a90a3fb5
spl set id: 47f3804a-c7fc-4a12-a15c-981bcab9e120

Reported adverse events (FAERS/openFDA)#

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