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Lidocaine Hydrochloride by Safetec of America, Inc.

Medically reviewed on November 1, 2017

Dosage form: liquid
Ingredients: Lidocaine Hydrochloride 20mg in 1mL
Labeler: Safetec of America, Inc.
NDC Code: 61010-5100

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

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

  • Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

Directions
  • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • for children under 2 years of age consult a physician

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Manufactured by SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077 www.safetec.com

PAIN RELIEF – Burn Spray 
Safetec of America

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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PRINCIPAL DISPLAY PANEL – 3 oz. bottle

NDC 61010-5100-3

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

3 fl. oz. (88.7 ml)

Reorder no. 50104

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
propylene glycol 
diazolidinyl urea 
water 
Packaging
#Item CodePackage Description
1NDC:61010-5100-388.7 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/02/2011
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-5100)

 
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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