FIRST AID AND BURN- benzalkonium chloride and lidocaine hydrochloride cream 
Acme United Corporation

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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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

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

Other information

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

PRINCIPAL DISPLAY PANEL – 10 count box
FIRST AID AND BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0924-5701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1.3 mg  in 1 g
lidocaine hydrochloride (lidocaine) lidocaine hydrochloride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
alcohol 
methylparaben 
mineral oil 
paraffin 
propylparaben 
water 
petrolatum 
white wax 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5701-0410 in 1 BOX
1NDC:0924-5701-010.9 g in 1 PACKET
2NDC:0924-5701-0910 in 1 BOX
2NDC:0924-5701-010.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/27/2012
Labeler - Acme United Corporation (001180207)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0924-5701)

Revised: 2/2013
Document Id: 847a8aff-6b66-427d-8bd6-e268dcc4feaf
Set id: 75bfd7f9-22e6-4ed9-ad96-961b0355d73e
Version: 2
Effective Time: 20130212
 
Acme United Corporation