Phe-plp A&e Deep Throat Desensitizing Spray-peppermint

Phe-plp A&e Deep Throat Desensitizing Spray-peppermint
SPL v1
SPL
SPL Set ID 4355e0d0-1222-d594-e063-6294a90abb29
Route
TOPICAL
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (3 mg)
Inactive Ingredients
Alcohol Glycerin Acesulfame Potassium Sucralose Citric Acid Sodium Benzoate Water Peppermint Oil Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Benzocaine (7.5%)

Purpose

Desensitizer


Medication Information

Purpose

Desensitizer

Description

Benzocaine (7.5%)

Use

For occasional personal use to help prevent the gag reflex.

Section 50565-1

Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

pale, gray, or blue colored skin (cyanosis)

headache

rapid heart rate

shortness of breath

dizziness or lightheadedness

fatigue or lack of energy

Directions

Adults 18 years of age and older: Apply 2-3 sprays to the back of the throat. Limit use to 3-4 times per day.

For adults only. Not for sale to minors.

Other Information

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine (7.5%)

Inactive Ingredients

Purified Water, Glycerin, Alcohol, Acesulfame Potassium, Sucralose, Potassium Sorbate, Sodium Benzoate, Citric Acid, Natural Flavor (Peppermint)

Package Label Principal Display Panel


Structured Label Content

Use

For occasional personal use to help prevent the gag reflex.

Section 50565-1 (50565-1)

Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion

Purpose

Desensitizer

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

pale, gray, or blue colored skin (cyanosis)

headache

rapid heart rate

shortness of breath

dizziness or lightheadedness

fatigue or lack of energy

Directions

Adults 18 years of age and older: Apply 2-3 sprays to the back of the throat. Limit use to 3-4 times per day.

For adults only. Not for sale to minors.

Other Information (Other information)

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine (7.5%)

Inactive Ingredients (Inactive ingredients)

Purified Water, Glycerin, Alcohol, Acesulfame Potassium, Sucralose, Potassium Sorbate, Sodium Benzoate, Citric Acid, Natural Flavor (Peppermint)

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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