XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE- lidocaine gel

Xesso Strawberry Rear Comfort Glide 4% Lidocaine by

Drug Labeling and Warnings

Xesso Strawberry Rear Comfort Glide 4% Lidocaine by is a Otc medication manufactured, distributed, or labeled by Premium Natural Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

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.

Purpose

Anorectal

Use

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

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.

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.

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.

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.

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.

Inactive Ingredients

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

Principle Display Panel

INGREDIENTS AND APPEARANCE

XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81777-105
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4.625 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)	0.5 g  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.5 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	54.3 g  in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.3 g  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	0.7 g  in 100 mL
ISOPENTYLDIOL (UNII: 19NOL5474Q)	0.4 g  in 100 mL
WATER (UNII: 059QF0KO0R)	38.76 g  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81777-105-01	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	12/13/2022

Labeler - Premium Natural Cosmetics Inc (051403646)