LANACANE MAXIMUM STRENGTH ANTI-ITCH- benzethonium chloride and benzocaine cream
RB Health (US) 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.

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Lanacane® Maximum Strength Anti-Itch Cream

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 of 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 years of age: 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, retinyl palmitate, sorbitan monostearate, stearamidopropyl PG-dimonium chloride phosphate, water

Questions?

1-866-252-5327.

You may also report side effects to this phone number.

Distributed by: RB Health (US)
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 Relieving Cream)

2-in-1

FAST Acting
Itch Relief

Kills Germs*
*unlike Hydrocortisones

Temporary itch relief from:

Insect bites
Rashes
Dry, Itchy skin

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzethonium chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)	Benzethonium chloride	2 mg in 1 g
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
acetylated lanolin alcohols (UNII: SNN716810P)
aloe (UNII: V5VD430YW9)
cetyl acetate (UNII: 4Q43814HXS)
cetyl alcohol (UNII: 936JST6JCN)
cholecalciferol (UNII: 1C6V77QF41)
corn oil (UNII: 8470G57WFM)
dimethicone (UNII: 92RU3N3Y1O)
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
isopropyl myristate (UNII: 0RE8K4LNJS)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
PEG-100 stearate (UNII: YD01N1999R)
propylparaben (UNII: Z8IX2SC1OH)
pyrithione zinc (UNII: R953O2RHZ5)
sorbitan monostearate (UNII: NVZ4I0H58X)
stearamidopropyl propylene glycol-dimonium chloride phosphate (UNII: W6000VEI5Y)
vitamin A palmitate (UNII: 1D1K0N0VVC)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-810-01	1 in 1 CARTON	09/28/2012
1		28 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	09/28/2012

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: 27093f0a-7535-4869-8ef2-82c7c8c04095

Set id: 96eb2dcc-4653-452a-9abd-fe92114a14ad

Version: 6

Effective Time: 20220124

RB Health (US) LLC