FIRST AID AND BURN- benzalkonium chloride, 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

Topical analgesic

Uses

Warnings

For external use only

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center right away.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Stop use and ask a doctor if

  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years and over: clean affected area, apply small amount not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Other information

Inactive ingredients

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

Questions?

1-800-275-3433

PRINCIPAL DISPLAY PANEL – Pac-Kit 12 count box

PAC-KIT
FIRST AID

First Aid
Burn Cream
Packets

Paquetes de crema
para quemaduras

12 First Aid Burn
Cream Packets,
0.9gm ea.

12 paquetes,
0,9 gm cada uno.

Reorder #13-006

ANSI Z308. 1-2009

PRINCIPAL DISPLAY PANEL – Pac-Kit 12 count box
FIRST AID AND BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 g
lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) lidocaine hydrochloride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
alcohol (UNII: 3K9958V90M)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
white wax (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5701-0512 in 1 BOX
1NDC:0924-5701-010.9 g in 1 PACKET
2NDC:0924-5701-0625 in 1 BOX
2NDC:0924-5701-010.9 g in 1 PACKET
3NDC:0924-5701-0760 in 1 BOX
3NDC:0924-5701-010.9 g in 1 PACKET
4NDC:0924-5701-08144 in 1 BOX
4NDC: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: 5/2012
Document Id: f71543e8-a6fb-4d21-9e89-f77005322002
Set id: 9fa378a0-afb5-4a98-88d0-e4512296f446
Version: 1
Effective Time: 20120524
 
Acme United Corporation