Inked-plp Naughty Kitty Kat

Inked-plp Naughty Kitty Kat
SPL v2
SPL
SPL Set ID 170eb644-c72c-5744-e063-6394a90a767d
Route
ORAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (3 mg) Glycerin (30 mg)
Inactive Ingredients
Water Sucralose Acesulfame Potassium Alcohol Citric Acid Monohydrate Sodium Benzoate Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-27

Description

Benzocaine 3% ................. Desensitizer Glycerin 30% ...................... Demulcent

Purpose

Desensitizer Demulcent


Medication Information

Purpose

Desensitizer Demulcent

Description

Benzocaine 3% ................. Desensitizer Glycerin 30% ...................... Demulcent

Use

For occasional personal use to help prevent the gag reflex

Section 50565-1

Keep away from children.

Section 50566-9

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.

Section 50567-7

Avoid contact with the eyes. Do not use an irritated or infected skin.

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 the 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

This product is not a contraceptive and contains no spermicide.

Directions

Adults: Before applying this product, gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth.

Apply up to 6 times daily. Children under 12 years: consult a doctor.

Other Information

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine 3% ................. Desensitizer Glycerin 30% ...................... Demulcent

Inactive Ingredients

Alcohol, Purifi ed Water, Acesulfame Potassium, Sucralose, Nat. & Art. Flavors, Citric Acid, Potassium Sorbate, Sodium Benzoate

Package Label Principal Display Panel

30mL NDC: 84243-211-11


Structured Label Content

Use

For occasional personal use to help prevent the gag reflex

Section 50565-1 (50565-1)

Keep away from children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

Avoid contact with the eyes. Do not use an irritated or infected skin.

Purpose

Desensitizer Demulcent

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 the 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

This product is not a contraceptive and contains no spermicide.

Directions

Adults: Before applying this product, gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth.

Apply up to 6 times daily. Children under 12 years: consult a doctor.

Other Information (Other information)

Store at 20-25°C (68-77°F)

Active Ingredient(s)

Benzocaine 3% ................. Desensitizer Glycerin 30% ...................... Demulcent

Inactive Ingredients (Inactive ingredients)

Alcohol, Purifi ed Water, Acesulfame Potassium, Sucralose, Nat. & Art. Flavors, Citric Acid, Potassium Sorbate, Sodium Benzoate

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

30mL NDC: 84243-211-11


Advanced Ingredient Data


Raw Label Data

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