SPL v5
SPL
SPL Set ID 9c24dcff-3988-40eb-821a-fd4b0c85f528
Route
TOPICAL
Published
Effective Date 2024-05-07
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 Chondroitin Sulfate (bovine) 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-26

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.

Section 50565-1

Warnings

For external use only.

Do not use onwounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children and petsIf swallowed get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Drug Facts

Product Label

Active Ingredient

Tetracaine 2%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Purpose

External Analgesic

Warnings

For external use only.

Do not use onwounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children and petsIf swallowed get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Tetracaine 2%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine


Advanced Ingredient Data


Raw Label Data

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