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First Aid and Burn by Safetec of America, Inc.

Dosage form: cream
Ingredients: benzalkonium chloride 1.3mg in 1g, lidocaine hydrochloride 5mg in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-5701

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.

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

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
  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

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 61010-5701-03

Safetec

First Aid &
Burn Cream

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – 144 count box

NDC 61010-5701-4

Safetec

First Aid

First Aid & Burn Cream

  • For Temporary Relief of
    Pain Associated with
    Minor Burns
  • Helps Protect Against
    Harmful Bacteria

Reorder No. 53410
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com

FIRST AID AND BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5701
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 Hydrochloride Anhydrous5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
alcohol 
methylparaben 
mineral oil 
paraffin 
propylparaben 
water 
petrolatum 
white wax 
Packaging
#Item CodePackage Description
1NDC:61010-5701-4144 PACKET in 1 BOX
1NDC:61010-5701-30.9 g in 1 PACKET
2NDC:61010-5701-525 PACKET in 1 BOX
2NDC:61010-5701-30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/21/2012
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-5701)

Revised: 09/2012
 
Safetec of America, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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