Phe-plp A&e A&e Easy Anal Gel

Phe-plp A&e A&e Easy Anal Gel
SPL v1
SPL
SPL Set ID 4355e0f3-65ba-eca6-e063-6394a90ab43c
Route
TOPICAL
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (3.5 mg)
Inactive Ingredients
Water Potassium Sorbate Propylene Glycol Hydroxyethyl Cellulose, Unspecified Sodium Benzoate Glycerin Citric Acid

Identifiers & Packaging

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

Description

Benzocaine (3.5%)

Purpose

Desensitizer


Medication Information

Purpose

Desensitizer

Description

Benzocaine (3.5%)

Use

Helps with temporary relief of discomfort

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

Apply to rectal area before penetration, no more than 3–4 times daily. Wait a few minutes for desensitizing to take effect. Rub into the skin and wipe off any residue. Wash product off after intercourse with warm water and soap.

Other Information

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine (3.5%)

Inactive Ingredients

Purified Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Citric Acid.

Package Label Principal Display Panel


Structured Label Content

Use

Helps with temporary relief of discomfort

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

Apply to rectal area before penetration, no more than 3–4 times daily. Wait a few minutes for desensitizing to take effect. Rub into the skin and wipe off any residue. Wash product off after intercourse with warm water and soap.

Other Information (Other information)

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine (3.5%)

Inactive Ingredients (Inactive ingredients)

Purified Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Citric Acid.

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


Advanced Ingredient Data


Raw Label Data

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