LIDOCAINE 4% TOPICAL ANESTHETIC CREAM- lidocaine 4% cream cream

Lidocaine 4% Topical Anesthetic Cream by

Drug Labeling and Warnings

Lidocaine 4% Topical Anesthetic 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 4% w/w

Purpose

Topical Anesthetic

Uses temporarily relieves pain and itching due to:

• minor cuts
• minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

Warnings

For external use only

When using this product

• do not use in or near the eyes
• do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children

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

Directions

• 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

Other information

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

Inactive ingredients

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

Dosage

40 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 4% TOPICAL ANESTHETIC CREAM 
lidocaine 4% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73715-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4.27 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	2 g  in 100 g
WATER (UNII: 059QF0KO0R)	80.48 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73715-001-01	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
OTC Monograph Drug	M017	06/15/2020

Labeler - Mohnark Pharmaceuticals Inc. (117013830)

Establishment
Name	Address	ID/FEI	Business Operations
Mohnark Pharmaceuticals Inc.		117013830	manufacture(73715-001)