sunset novelties- plp numbing spray

sunset novelties- plp numbing spray
SPL v1
SPL
SPL Set ID 2ceeca3e-9197-9166-e063-6394a90ae908
Route
topical
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
anhydrous citric acid potassium sorbate sodium benzoate hydroxyethylcellulose propylene glycol water glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01

Purpose

External Analgesic

Description

Lidocaine HCI 3.5%


Medication Information

Warnings

For external use only. Do not use this product with a mechanical device.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Do not exceed the daily recommended dosage.

In case of any bleeding, discontinue use and consult a doctor.

Keep this and all drugs out of reach of children. In case of accidential overdose, seek medical help or call a Poison Control Center right away.

As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

Purpose

External Analgesic

Directions

Apply to any area of the body where you desire extra moisture. Secure cap.

Apply externally to the affected area up to 6 times

Other Information

Store at 20-25°C (68-77°F)

Inactive Ingredients

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

Description

Lidocaine HCI 3.5%

Use

For temporary relief of pain, soreness or burning in the perianal area.

Section 50565-1

Keep out of reach of childeren.

Active Ingredient(s)

Lidocaine HCI 3.5%

Package Label Principal Display Panel

118 mL NDC: 85243-111-11


Structured Label Content

Warnings

For external use only. Do not use this product with a mechanical device.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Do not exceed the daily recommended dosage.

In case of any bleeding, discontinue use and consult a doctor.

Keep this and all drugs out of reach of children. In case of accidential overdose, seek medical help or call a Poison Control Center right away.

As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

Purpose

External Analgesic

Directions

Apply to any area of the body where you desire extra moisture. Secure cap.

Apply externally to the affected area up to 6 times

Other Information (Other information)

Store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

Use

For temporary relief of pain, soreness or burning in the perianal area.

Section 50565-1 (50565-1)

Keep out of reach of childeren.

Active Ingredient(s)

Lidocaine HCI 3.5%

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

118 mL NDC: 85243-111-11


Advanced Ingredient Data


Raw Label Data

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