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NDC 63824-0820-35 Lanacane First Aid 2; 200 mg/g; mg/g Details

Lanacane First Aid 2; 200 mg/g; mg/g

Lanacane First Aid is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZETHONIUM CHLORIDE; BENZOCAINE.

Product Information

NDC	63824-0820
Product ID	63824-820_829224e0-c8d6-4a86-8791-6aecaedc0348
Associated GPIs	90859902173240
GCN Sequence Number	058845
GCN Sequence Number Description	benzocaine/benzethon Cl AEROSOL 20 %-0.2 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	24366
HICL Sequence Number	000338
HICL Sequence Number Description	BENZOCAINE/BENZETHONIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	Lanacane First Aid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzethonium chloride and Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	2; 200
Active Ingredient Units	mg/g; mg/g
Substance Name	BENZETHONIUM CHLORIDE; BENZOCAINE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63824-0820-35 (63824082035)

Pricing Information	N/A
NDC Package Code	63824-820-35
Billing NDC	63824082035
Package	99 g in 1 CAN (63824-820-35)
Marketing Start Date	2012-06-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4b965cd3-bfe4-4aad-a52c-b747696baa1c Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Benzethonium chloride 0.2%	First-aid antiseptic
Benzocaine 20%	Pain relieving spray

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

Flammable do not use near heat, flame or fire or while smoking

Do not use

in the eyes
over large areas of the body

When using this product

do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Consult a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and consult a doctor if

condition worsens
condition persists for more than 7 days
symptoms clear up and occur again within a few days

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 spray a small amount of this product on the area not more than1 to 3 times daily
children under 2 years of age: consult a doctor
may be covered with a sterile bandage
if bandaged, let dry first

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

alcohol (24.5% v/v), aloe, cyclomethicone, dipropylene glycol, dl-alpha tocopherol acetate, isobutane

Questions?

1-866-252-5327

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US)

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 99 g Can Label

NDC 63824-820-35

LANACANE®

+

FIRST AID

SPRAY

Benzethonium chloride 0.2% First-Aid Antiseptic

Benzocaine 20% Pain Relieving Spray

2-in-1

FAST Acting

Pain Relief

+

Kills Germs

Cools and Soothes Instantly

First Aid for:

Minor Cuts/Scrapes
Sunburn

NET WT. 3.5 OZ (99 g)

PRINCIPAL DISPLAY PANEL - 99 g Can Label

INGREDIENTS AND APPEARANCE

LANACANE FIRST AID

benzethonium chloride and benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-820
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
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOBUTANE (UNII: BXR49TP611)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-820-35	99 g in 1 CAN; Type 0: Not a Combination Product	06/19/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	06/19/2012

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: 829224e0-c8d6-4a86-8791-6aecaedc0348

Set id: 4b965cd3-bfe4-4aad-a52c-b747696baa1c

Version: 4

Effective Time: 20220128

Search by Drug Name or NDC

NDC 63824-0820-35 Lanacane First Aid 2; 200 mg/g; mg/g Details

Lanacane First Aid 2; 200 mg/g; mg/g

Product Information

Package

Package Images

NDC 63824-0820-35 (63824082035)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4b965cd3-bfe4-4aad-a52c-b747696baa1c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 99 g Can Label

INGREDIENTS AND APPEARANCE

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