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

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61010-5000, Burn Gel

Pain Relief

Drug Facts

Active Ingredient

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 doctorif condition worsens or persists for more than 7 days or clears up and occurs again within a few days

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away

Directions

Inactive ingredients

aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

NDC 61010-5000-0

Safetec

Burn Gel

For Temporary
Pain Relief of
Minor Burns

0.125 oz. (3.7 ml)
Reorder no. 50000

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

NDC 61010-5000-1

Safetec

First Aid
Burn Gel

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)
Reorder no. 50001

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

Principal Display Panel - Pouch label

Safetec

Burn Gel

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - Pouch label

Principal Display Panel - 144 Box label

NDC 61010-5000-04

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

Reorder No. 50007

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - 144 Box label

Principal Display Panel - 25 Box label

NDC 61010-5000-5

Safetec

First Aid

Burn Gel

For Temporary Pain Relief
of Minor Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel - 25 Box label

Principal Display Panel – 10 Packet Box Label

Safetec ®

First Aid

Burn Gel

Quickly soothes pain
caused by minor burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 50028

Principal Display Panel – 10 Packet Box Label
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-5000-03.3 g in 1 PACKET; Type 0: Not a Combination Product09/19/2012
2NDC:61010-5000-1121.2 g in 1 BOTTLE; Type 0: Not a Combination Product09/19/2012
3NDC:61010-5000-30.9 g in 1 POUCH; Type 0: Not a Combination Product09/19/2012
4NDC:61010-5000-4144 in 1 CARTON09/19/2012
40.9 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:61010-5000-525 in 1 CARTON09/19/2012
50.9 g in 1 POUCH; Type 0: Not a Combination Product
6NDC:61010-5000-610 in 1 BOX04/01/2020
60.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/19/2012
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-5000)

Revised: 2/2024
Document Id: 10d33035-4a33-6917-e063-6294a90ac896
Set id: 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925
Version: 5
Effective Time: 20240207
 
Safetec of America, Inc.