Tetri-AG by Singular Dreamer, Ltd dba True Marker

Tetri-AG by

Drug Labeling and Warnings

Tetri-AG by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Minor burns 
• Minor cuts 
• Scrapes 
• Sunburn

Warnings

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:

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:

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

TETRI-AG 
tetracaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-7120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	1.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83035-7120-3	1 in 1 BOTTLE	01/24/2024	11/01/2024
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/24/2024	11/01/2024

Labeler - Singular Dreamer, Ltd dba True Marker (129504103)

Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 10/2024

Document Id: 2516c364-b6e4-de9f-e063-6394a90a3fb5

34390-5

Set id: 47f3804a-c7fc-4a12-a15c-981bcab9e120

Version: 2

Effective Time: 20241022