Xesso Strawberry Rear Comfort Glide 4% Lidocaine

Xesso Strawberry Rear Comfort Glide 4% Lidocaine
SPL v5
SPL
SPL Set ID efba09fc-6dd7-0f73-e053-2995a90a628a
Route
RECTAL
Published
Effective Date 2022-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Methylparaben Propylparaben Glycerin Diazolidinyl Urea Carboxymethylcellulose Sodium, Unspecified Form Isopentyldiol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-13

Description

Lidocaine 4%

Purpose

Anorectal


Medication Information

Purpose

Anorectal

Description

Lidocaine 4%

Use

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

Stop Use

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

Warnings

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.

• Do not apply onto cracked or broken skin.

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

Directions
  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 4%

Other Information

Other Information:

• Store at room temperature 20 - 25°C (68 - 77°F).

• Do not use if tamper evident seal on the outside of the container is broken or missing.

Ask A Doctor Section

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

Inactive Ingredients

Inactive Ingredients: Carboxymethylcellulose Sodium, Diazolidinyl urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Water, Natural Flavor.

Principle Display Panel

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.


Structured Label Content

Use

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

Purpose

Anorectal

Stop Use

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

Warnings

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.

• Do not apply onto cracked or broken skin.

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

Directions
  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Other Information:

• Store at room temperature 20 - 25°C (68 - 77°F).

• Do not use if tamper evident seal on the outside of the container is broken or missing.

Ask A Doctor Section (Ask a doctor section)

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

Inactive Ingredients

Inactive Ingredients: Carboxymethylcellulose Sodium, Diazolidinyl urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Water, Natural Flavor.

Principle Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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