DERMA-CAINE- benzalkonium chloride and lidocaine hydrochloride cream 
Unifirst First Aid 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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Burn Cream with Lidocaine

Pain Relief

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 provide temporary relief of pain or discomfort in:

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use:

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • ask a doctor before use in case of or deep puncture wounds, animal bites or serious burns

Stop use and ask doctor if:

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on 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 15 to 25 C (59 to 79 F)
  • Lot No. & Exp. Date: see foil packet

Inactive ingredients

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

Questions or comments?

1-800-869-6970

PRINCIPAL DISPLAY PANEL – 20 count box

Derma-Caine
burn cream

Creama para quemaduras

With Aloe Vera to add moisture

For Minor Burns
Soothing
Promotes Healing
Lessens Chance of Infection

1.0 Gram 20 Single Dose Packets
Distributed by Green Guard®, St. Louis, Missouri 63045

PRINCIPAL DISPLAY PANEL – 20 count box

PRINCIPAL DISPLAY PANEL – packet

Derma-Caine
burn cream

With Aloe Vera To Add Moisture
Topical Antiseptic plus Analgesic

Dist by GREEN GUARD

Package not child-resistant

Net Wt. 1.0 g. (1/28 oz.)

PRINCIPAL DISPLAY PANEL – packet
DERMA-CAINE 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47682-399
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 Hydrochloride Anhydrous5.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
alcohol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
white wax 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-399-7120 in 1 BOX
1NDC:47682-399-991.0 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2012
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(47682-399)

Revised: 3/2014
Document Id: 5a8d2d1b-b06e-450f-a407-3c8eddef3c76
Set id: f7c8eed6-4be9-4306-88a3-a3a45c678010
Version: 1
Effective Time: 20140303
 
Unifirst First Aid Corporation