RxNorm Names

Review RxNorm Normal Forms

FIRST AID AND BURN (benzalkonium chloride, lidocaine hydrochloride) cream
[Acme United Corporation]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75bfd7f9-22e6-4ed9-ad96-961b0355d73e

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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 Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

External analgesic

Uses

first aid to help prevent infection and for the temporary relief of itching associated with

minor cuts
scrapes
burns

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body
longer than 1 week unless directed by a doctor
in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

When using this product avoid contact with eyes

Stop use and ask a doctor if

condition worsens or persists for more than 7 days
clears up and occurs 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
apply a small amount of this product to the area 1 to 3 times daily
may be covered with a sterile bandage
children under 2 years of age: consult a doctor

Other information

store at room temperature
do not use if packet is opened or torn

Inactive ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Questions? 1-800-835-2263

REORDER
www.PhysiciansCareFirstAid.com
1 800 835 2263

PRINCIPAL DISPLAY PANEL – 0.9 gram packet

NDC 0924-5701-01

PhysiciansCARE

Burn Cream

0.9 g (1/32 oz.)

Acme United Corporation

Fairfield, CT 06824 800-835-2263

PRINCIPAL DISPLAY PANEL – 0.9 gram packet

PRINCIPAL DISPLAY PANEL – 10 count box

PhysiciansCARE

Burn Cream

Benzalkonium chloride First aid antiseptic
Lidocaine HCl External Analgesic

10 Single use Packets 0.9 g each

Reorder No. 51014

ANSI Z308.1

FIRST AID AND BURN
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-5701
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (benzalkonium)	benzalkonium chloride	1.3 mg in 1 g
lidocaine hydrochloride (lidocaine)	lidocaine hydrochloride	5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf
alcohol
methylparaben
mineral oil
paraffin
propylparaben
water
petrolatum
white wax

Packaging
#	Item Code	Package Description
1	NDC:0924-5701-04	10 in 1 BOX
1	NDC:0924-5701-01	0.9 g in 1 PACKET
2	NDC:0924-5701-09	10 in 1 BOX
2	NDC:0924-5701-01	0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/27/2012

Labeler - Acme United Corporation (001180207)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0924-5701)

Revised: 02/2013

Document Id: 847a8aff-6b66-427d-8bd6-e268dcc4feaf

Set id: 75bfd7f9-22e6-4ed9-ad96-961b0355d73e

Version: 2

Effective Time: 20130212