XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE- lidocaine gel 
Premium Natural Cosmetics Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Xesso Strawberry Rear Comfort Glide 4% Lidocaine

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

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

PDP

XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81777-105
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4.625 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81777-105-01245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01512/13/2022
Labeler - Premium Natural Cosmetics Inc (051403646)

Revised: 10/2023
Document Id: 06c311d7-6741-f659-e063-6294a90a4b99
Set id: efba09fc-6dd7-0f73-e053-2995a90a628a
Version: 2
Effective Time: 20231002
 
Premium Natural Cosmetics Inc