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 4%

Ask a doctor section

Ask a health professional before using this product.

Do not Use

• Do not exceed the daily recommended dosage.
• Do not apply onto cracked or broken skin.
• In case of bleeding, discontinue use and consult a doctor.

Keep out of reach of children

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

Purpose Section

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, irritaition, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

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

Pregnancy or Breast Feeding Section

As with any drug, consult a health care professional if you are pregnant or nursing.

Inactive Ingredients

Carboxymethylcellulose sodium, diazolidinyl urea, glycerin, isopentyldiol, methylparaben, propylparaben, water

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.

Use

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

Warning

Other Information

• Store at room temperature 20 - 25 C (68 - 77F)
• Do not use if tamper evident seal on the outside of the container is broken or missing.

PRINCIPAL DISPLAY PANEL

Xesso Black

Rear Comfort Glide

Slippery and Mild Numbing

Thick, Water-Based Formula

PEG-Free and Oil-Free

8.3 fl oz | 245 mL

Rear Comfort Glide 16 fl oz

4 fl oz Label PDP

INGREDIENTS AND APPEARANCE

XESSO REAR COMFORT GLIDE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81777-101
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
WATER (UNII: 059QF0KO0R)	46.282 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	46.911 g  in 100 mL
ISOPENTYLDIOL (UNII: 19NOL5474Q)	0.864 g  in 100 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	0.05 g  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.05 g  in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.3 g  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	0.454 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81777-101-01	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2021
2	NDC: 81777-101-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/05/2022
3	NDC: 81777-101-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	06/01/2021

Labeler - Premium Natural Cosmetics Inc (051403646)