LIDOCAINE- lidocaine cream
Alvogen Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% Topical Anesthetic Cream

Drug Facts

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves pain and itching due to:

minor cuts
sunburn
minor scrapes
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 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, lecithin, propylene glycol, purfied water, vitamin E acetate.

Distributed by:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

Toll Free: 1-866-770-3024

Lidocaine 4% - carton

NDC 47781-570-73

Lidocaine 4%

Topical Anesthetic Cream

NET WT. 30 grams

30gram-carton

LIDOCAINE
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47781-570
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47781-570-89	5 in 1 CARTON	01/12/2018	09/01/2022
1		5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:47781-570-47	5 in 1 CARTON	02/19/2018	09/01/2022
2		5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:47781-570-72	1 in 1 CARTON	02/19/2018	09/01/2022
3		15 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:47781-570-73	1 in 1 CARTON	02/19/2018	09/01/2022
4		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/12/2018	09/01/2022

Labeler - Alvogen Inc. (008057330)

Revised: 3/2021

Document Id: 7c7dec71-c399-eddf-efe8-c507dcb70026

Set id: 21ef5e41-7b70-c913-803b-98b37271180d

Version: 5

Effective Time: 20210325

Alvogen Inc.