LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride liquid 
Safetec of America, Inc.

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61010-5100, Burn Spray

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 doctorif 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

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

PRINCIPAL DISPLAY PANEL – 3 oz. bottle

PRINCIPAL DISPLAY PANEL – 2 oz. bottle

NDC 61010-5100-4

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 50004

PRINCIPAL DISPLAY PANEL – 2 oz. bottle

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

NDC 61010-5100-5

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)

Reorder no. 50005

PRINCIPAL DISPLAY PANEL – 4 oz. bottle
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-5100-459.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/02/2011
2NDC:61010-5100-5118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/02/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/02/2011
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-5100)

Revised: 2/2024
Document Id: 114b1a82-0728-fe2e-e063-6394a90a309e
Set id: 8eb3e7e2-26e5-430e-89aa-40a0367c637e
Version: 7
Effective Time: 20240207
 
Safetec of America, Inc.