LIDOCAINE ROLL-ON- lidocaine gel

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts - Active Ingredient

Lidocaine 5%

Purpose

Anorectal (hemorrhoidal)

Uses

• Helps relieve local itching and discomfort in the perianal area
• For the temporary relief of pain, irritation or burning
• Temporarily shrinks hemorrhoidal tissue

Warnings

For external use only

• Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using your fingers or any mechanical device or applicator.
• Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
• When using this product if the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly.
• Stop use and ask a doctor if the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
• Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
• Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

Pregnancy or Breast-Feeding Warning

If pregnant or breast-feeding, ask a health professional before use

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse 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 or after each bowel movement.

Children under 12 years of age: consult a doctor.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polysorbate 60, Sodium Hydroxide, Water (Aqua).

Questions?

Call 1-866-933-6337

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE ROLL-ON 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER (UNII: 0A5MM307FC)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-023-74	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/27/2026

Labeler - YYBA Corp (006339772)

Registrant - YYBA Corp (006339772)