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

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

Keep out of reach of children.

If ingested contact a Poison Control Center right away.

Directions

Inactive ingredients

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

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 – Physicians Care bag (0924-5701-03)

Item # 806031

PhysiciansCARE

FIRST AID & BURN
CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263

PRINCIPAL DISPLAY PANEL –  Physicians Care bag (0924-5701-03)

PRINCIPAL DISPLAY PANEL – Pac-Kit bag (0924-5701-02)

Unit 13-006 B

PAC-KIT FIRST AID

FIRST AID & BURN
CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263

PRINCIPAL DISPLAY PANEL –  Pac-Kit bag (0924-5701-02)
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:0924-5701-026 in 1 BAG
1NDC:0924-5701-010.9 g in 1 PACKET
2NDC:0924-5701-036 in 1 BAG
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

Revised: 1/2012
Document Id: 3a6943c0-276c-4e76-a2a8-948163263d18
Set id: e76c059a-ac6f-46a9-a9b9-2a20ed532cd4
Version: 1
Effective Time: 20120127
 
Acme United Corporation