TETRI-AG- tetracaine ointment 
Singular Dreamer, Ltd dba True Marker

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Active Ingredient   Purpose

Tetracaine 1.9%.       Topical Analgesic

Use

For the temporary relief of: Pain, associated with

Warnings

For external use only.

Do not use

When using this product

Stop use and ask a doctor if:

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:

Adults and children 2 years of age and older:


Children under 2 years of age:

Other Information:

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

Inactive Ingredients:

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

Questions or comments?

Call 1-888-811-2634

Product label

image description

TETRI-AG 
tetracaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-7120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE1.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83035-7120-31 in 1 BOTTLE01/24/2024
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/24/2024
Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 1/2024
Document Id: 1029831b-1dac-b8f3-e063-6294a90ad771
Set id: 47f3804a-c7fc-4a12-a15c-981bcab9e120
Version: 1
Effective Time: 20240130
 
Singular Dreamer, Ltd dba True Marker