LIDOCAINE 3% TOPICAL ANESTHETIC CREAM cream

Lidocaine 3% Topical Anesthetic Cream by

Drug Labeling and Warnings

Lidocaine 3% Topical Anesthetic Cream by is a Otc medication manufactured, distributed, or labeled by Brookfield Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 3% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves pain and itching due to

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

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve in 7 days
• symtpoms 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 sweallowed, 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 to 4 times a day
• Children under 2 years: as a doctor

Other information

• May be applied under occlusive dressing.
• Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF). See USP Controlled Room Temperature.

Inactive ingredients

benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, triethanolamine*, vitamine E acetate.

*May contain this ingredient.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 3% TOPICAL ANESTHETIC CREAM 
lidocaine 3% topical anesthetic cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71351-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71351-015-01	1 in 1 CARTON	07/16/2018
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71351-015-03	1 in 1 CARTON	07/16/2018
2		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/16/2018

Labeler - Brookfield Pharmaceuticals, LLC (080592685)

Registrant - Brookfield Pharmaceuticals, LLC (050592685)