LANACANE MAXIMUM STRENGTH ANTI-ITCH - benzethonium chloride and benzocaine cream
Reckitt Benckiser LLC

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.

----------

Drug Facts

Active ingredients	Purpose
Benzethonium chloride 0.2%	First-aid antiseptic
Benzocaine 20%	Pain relief cream

Uses

first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use

in the eyes
over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition worsens
needed for longer than 1 week

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

Directions

adults and children 2 years of age and older: clean the affected area and apply a small amount to the affected area not more than 1 to 3 times daily
children under 2: ask a doctor
may be covered with a sterile bandage

Other information

store at 20-25°C (68-77°F)
retain carton for future reference

Inactive ingredients

acetylated lanolin alcohol, aloe, cetyl acetate, cetyl alcohol, cholecalciferol, corn oil, dimethicone, dl-alpha tocopherol acetate, fragrance, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, mineral oil, PEG-100 stearate, polyvinylpyrrolidone/eicosene copolymer, propylparaben, pyrithione zinc, sorbitan monostearate, stearamidopropyl PG-dimonium chloride phosphate, vitamin A palmitate, water

Questions?

1-866-252-5327

You may also report side effects to this phone number.

Distributed by Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 63824-810-01

LANACANE®

Maximum Strength

ANTI-ITCH
CREAM

Benzethonium chloride 0.2%
(First-Aid Antiseptic)
Benzocaine 20%
(Pain Relief Cream)

3 in 1

Soothes Itch
Relieves Pain
Anti-Bacterial
*unlike Hydrocortisones!

Cools and Soothes Instantly

First Aid for

: Minor Cuts/Scrapes/Burns
: Insect Bites
: Minor Skin Irritations

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

LANACANE MAXIMUM STRENGTH ANTI-ITCH
benzethonium chloride and benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-810
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzethonium chloride (Benzethonium)	Benzethonium chloride	2 mg in 1 g
Benzocaine (Benzocaine)	Benzocaine	200 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
acetylated lanolin alcohols
aloe
cetyl acetate
cetyl alcohol
cholecalciferol
corn oil
dimethicone
.alpha.-tocopherol acetate, dl-
glycerin
glyceryl monostearate
isopropyl myristate
methylparaben
mineral oil
PEG-100 stearate
propylparaben
pyrithione zinc
sorbitan monostearate
stearamidopropyl PG-dimonium chloride phosphate
vitamin A palmitate
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63824-810-01	1 TUBE in 1 CARTON	contains a TUBE
1		28 g in 1 TUBE	This package is contained within the CARTON (63824-810-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/20/2012

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2012 Reckitt Benckiser LLC