Cotr-plp Deep Throat

Cotr-plp Deep Throat
SPL v3
SPL
SPL Set ID 39c14a93-ef41-9cd5-e063-6294a90a636b
Route
TOPICAL
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (25 mg)
Inactive Ingredients
Acesulfame Potassium Sucralose Alcohol Water Citric Acid Sodium Benzoate Spearmint Potassium Sorbate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-15

Description

Benzocaine 2.5%

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 2.5%

Use

Temporarily reduces gag reflex by desensitizing the throat for deeper oral activity.

Section 50565-1

Keep out of reach of childeren.Contact Poison Control if

Warnings

For external use only. Do not apply to genitals or other body parts.

Allergy Alert: Avoid if allergic to benzocaine or other local anesthetics (e.g., lidocaine, procaine)

Do Not Use: If you have a history of methemoglobinemia or take related medications (e.g., nitrates, sulfonamides).

On irritated or broken mucous membranes.

When Using: Avoid eyes/nostrils; rinse if contact occurs.

Do not swallow immediately; allow throat numbing.

Avoid eating/drinking for 1 hour post-use to prevent choking.

Seek immediate medical help for excessive numbness, breathing issues, dizziness, or bluish skin.

Stop Use and Consult a Doctor If: Severe burning, swelling, irritation, rash, or prolonged numbing (>1-2 hours) occurs.

Ask a Doctor Before Use If: You have respiratory, heart, or liver issues, are pregnant/breastfeeding, or take interacting medications.

Keep Out of Reach of Children: Contact Poison Control

(1-800-222-1222) if swallowed.

• Other Warnings: Overuse may increase methemoglobinemia risk.

Avoid continuous/large

Directions

Adults (18+): 1-2 sprays to throat, max 3-4 per use.

Allow 30-60 seconds before swallowing; wait 1-2 minutes for full effect.

Numbing fades within 1 hour. Max 4 sprays/session, 12 sprays/24 hours.

Store at 68°-77°F, away from heat/sunlight.

Other Information

Active Ingredient(s)

Benzocaine 2.5%

Inactive Ingredients

Purified Water, Ethyl Alcohol, Glycerin, Acesulfame Potassium, Sucralose, Flavor, Citric Acid, Sodium Benzoate, Potassium

Package Label Principal Display Panel


Structured Label Content

Use

Temporarily reduces gag reflex by desensitizing the throat for deeper oral activity.

Section 50565-1 (50565-1)

Keep out of reach of childeren.Contact Poison Control if

Purpose

Oral Anesthetic

Warnings

For external use only. Do not apply to genitals or other body parts.

Allergy Alert: Avoid if allergic to benzocaine or other local anesthetics (e.g., lidocaine, procaine)

Do Not Use: If you have a history of methemoglobinemia or take related medications (e.g., nitrates, sulfonamides).

On irritated or broken mucous membranes.

When Using: Avoid eyes/nostrils; rinse if contact occurs.

Do not swallow immediately; allow throat numbing.

Avoid eating/drinking for 1 hour post-use to prevent choking.

Seek immediate medical help for excessive numbness, breathing issues, dizziness, or bluish skin.

Stop Use and Consult a Doctor If: Severe burning, swelling, irritation, rash, or prolonged numbing (>1-2 hours) occurs.

Ask a Doctor Before Use If: You have respiratory, heart, or liver issues, are pregnant/breastfeeding, or take interacting medications.

Keep Out of Reach of Children: Contact Poison Control

(1-800-222-1222) if swallowed.

• Other Warnings: Overuse may increase methemoglobinemia risk.

Avoid continuous/large

Directions

Adults (18+): 1-2 sprays to throat, max 3-4 per use.

Allow 30-60 seconds before swallowing; wait 1-2 minutes for full effect.

Numbing fades within 1 hour. Max 4 sprays/session, 12 sprays/24 hours.

Store at 68°-77°F, away from heat/sunlight.

Other Information (Other information)

Active Ingredient(s)

Benzocaine 2.5%

Inactive Ingredients (Inactive ingredients)

Purified Water, Ethyl Alcohol, Glycerin, Acesulfame Potassium, Sucralose, Flavor, Citric Acid, Sodium Benzoate, Potassium

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


Advanced Ingredient Data


Raw Label Data

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