LIDOCAINE gel

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient:

Lidocaine HCl 5.0%

Purpose

Anorectal (hemorrhoidal) cream

Uses:

helps relieve pain, itching, and burning associated with hemorrhoids and other anorectal disorders

Warnings:

For external use only

___________________

Do not use

• on large areas of the body or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When using this product

• use only as directed. Read and follow all directions and warnings on this carton
• do not allow contact with the eyes and mucous membranes
• do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

• condition worsens
• skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
• symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

• keep away from fire or flame

If pregnant or breast feeding

• ask a health professional before use

Keep out of reach of children and pets
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
Children 12 years and younger: ask a doctor

Inactive ingredients

Alcohol Denat., Aloe Barbadensis Leaf Juice, Carbomer, Chondroitin, Citric Acid, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Hydrogen Sulfate, Phenoxyethanol, Polysorbate 20, Potassium Hydroxide, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
CITRIC ACID (UNII: 2968PHW8QP)
ISOPROTERENONE HYDROGEN SULFATE (UNII: Q5F86EVY3Y)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-115-03	75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/31/2026

Labeler - YYBA Corp (006339772)

Registrant - YYBA Corp (006339772)