Lidocaine by Alvogen Inc. LIDOCAINE cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Alvogen Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

​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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Labeler - Alvogen Inc. (008057330)