LANACANE MAXIMUM STRENGTH ANTI-ITCH- benzethonium chloride and benzocaine cream

Lanacane by

Drug Labeling and Warnings

Lanacane by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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.

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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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/28/2012

Labeler - RB Health (US) LLC (081049410)