LIDOCAINE 5% TOPICAL ANORECTAL CREAM cream

Lidocaine 5% Topical Anorectal Cream by

Drug Labeling and Warnings

Lidocaine 5% Topical Anorectal Cream by is a Otc medication manufactured, distributed, or labeled by Mohnark Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 5% w/w

Purpose

Local Anesthetic

Uses

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

Warnings

For external use only

When using this product

• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
• Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: consult a doctor.

Other information

• Store at USP controlled room temperature 20-25 oC (68-77 oF).

Inactive ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

Dosage

50 milligrams/gram per application

Usage

• Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
• Children under 2 years of age: consult a doctor

Package Label

INGREDIENTS AND APPEARANCE

LIDOCAINE 5% TOPICAL ANORECTAL CREAM 
lidocaine 5% topical anorectal cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73715-002
Route of Administration	TOPICAL, RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	2 g  in 100 g
WATER (UNII: 059QF0KO0R)	80 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73715-002-01	30 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/15/2020

Labeler - Mohnark Pharmaceuticals Inc. (117013830)