XESSO REAR COMFORT GLIDE- lidocaine gel

Xesso Rear Comfort Glide by

Drug Labeling and Warnings

Xesso Rear Comfort Glide 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 2%

Ask a doctor

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. If case of accidental overdose, seek medical help or call a Poison Control Center right away.

Sop Use

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside of if redness, 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 are up to 6 times daily.

Warning

Other Information

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

Inactive Ingredients

Principal Display Panel

INGREDIENTS AND APPEARANCE

XESSO REAR COMFORT GLIDE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81777-104
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.35 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPENTYLDIOL (UNII: 19NOL5474Q)	0.4 g  in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.3 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	54.3 g  in 100 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	0.5 g  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)	41.25 g  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	0.7 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81777-104-01	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	11/10/2022

Labeler - PREMIUM NATURAL COSMETICS INC (051403646)