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 5% w/w

Purpose

Local anesthetic

Uses

Helps relieve pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.

When using this product

• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
• Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: consult a doctor.

Other information

• 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, purified water, vitamin E acetate.

SPL UNCLASSIFIED SECTION

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

Toll Free: 1-866-770-3024

Rev. 12/2016

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC: 47781-571-72

Lidocaine 5%
Anorectal Cream

NET WT. 15 grams

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47781-571
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	50 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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47781-571-72	1 in 1 CARTON	02/28/2018	09/01/2021
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 47781-571-73	1 in 1 CARTON	02/28/2018	09/01/2021
2		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 final	part346	02/28/2018	09/01/2021

Labeler - Alvogen Inc. (008057330)