SPL v1
SPL
SPL Set ID ec6f229a-331e-4b0d-91f1-056eef2eef8b
Route
TOPICAL
Published
Effective Date 2023-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracaine (2 g)
Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Propylene Glycol Stearic Acid Trolamine Elosulfase Alfa

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-03-31

Description

Tetracaine 2%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Tetracaine 2%

Uses

For temporary relief of pain and itching due to minor skin irritation.

Warnings

For external use only

Avoid contact with eyes

Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

Condition worsens or, if symptoms persists for more than 7 days or clear up and occur again within a few days. Discontinue use 

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times

daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label

Active Ingredient

Tetracaine 2%

Other Information

Protect this product from excessive heat and direct sun. 

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,

Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Questions and Comments?
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of pain and itching due to minor skin irritation.

Purpose

External Analgesic

Warnings

For external use only

Avoid contact with eyes

Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

Condition worsens or, if symptoms persists for more than 7 days or clear up and occur again within a few days. Discontinue use 

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times

daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Tetracaine 2%

Other Information (Other information)

Protect this product from excessive heat and direct sun. 

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,

Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Questions and Comments?
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)