Lidocaine HCl by Brookfield Pharmaceuticals, LLC LIDOCAINE HCL cream

Lidocaine HCl by

Drug Labeling and Warnings

Lidocaine HCl 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 HCl 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
• 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 to 4 times a day

Children under 2 years ask a doctor

Other information

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

Inactive ingredients

benzyl alcohol, carbomer, cholesterol, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, titanium dioxide, tocopheryl acetate.

Package Label

INGREDIENTS AND APPEARANCE

LIDOCAINE HCL 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71351-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71351-018-01	1 in 1 CARTON	11/14/2019
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71351-018-03	1 in 1 CARTON	11/14/2019
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	11/14/2019

Labeler - Brookfield Pharmaceuticals, LLC (080592685)

Registrant - Brookfield Pharmaceuticals, LLC (080592685)