Label: XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE- lidocaine gel
- NDC Code(s): 81777-105-01
- Packager: Premium Natural Cosmetics Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 2, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Ask a doctor section
- Purpose
- Use
- Keep out of reach of children
- Stop Use
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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.
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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
- Inactive Ingredients
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE
lidocaine gelProduct 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)
