Your browser does not support JavaScript! BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]
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BURN WITH LIDOCAINE (benzalkonium chloride, lidocaine hydrochloride) cream
[Unifirst First Aid Corporation]


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

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCl 2.0%

Purpose

First Aid Antiseptic

External analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • longer than 1 week, unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 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 and older:

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor

Other information

  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

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

Questions or comments?

1-800-634-7680

PRINCIPAL DISPLAY PANEL – box

MEDI-FIRST

BURN CREAM with Lidocaine

Antiseptic and pain relieving cream
for minor cuts, scrapes and burns

0.9g (1/32oz) Packets

25 per box

PRINCIPAL DISPLAY PANEL – box

PRINCIPAL DISPLAY PANEL – packet

First Aid Burn Cream
with Lidocaine

1/32oz.

ANTISEPTIC AND PAIN RELIEVING CREAM

(0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA

PRINCIPAL DISPLAY PANEL – packet
BURN WITH LIDOCAINE 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47682-260
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 Hydrochloride5.0 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:47682-260-7325 in 1 BOX
1NDC:47682-260-990.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/24/2012
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(47682-260)

Revised: 1/2012
 
Unifirst First Aid Corporation

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