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Lidocaine Hydrochloride by Safetec of America, Inc.

Dosage form: gel
Ingredients: Lidocaine Hydrochloride 20mg in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-5000

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.

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 doctor if 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
  • for adults and children 2 years and older: apply to affected area not more than 4 times daily
  • children under 2: do not use, consult a doctor

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 – 4 oz. bottle

NDC 61010-5000-4

Safetec

First Aid
Burn Gel

For Temporary
Pain Relief of
Minor Burns

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

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 - 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 - 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

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
propylene glycol 
diazolidinyl urea 
water 
menthol 
.alpha.-tocopherol acetate 
trolamine 
Packaging
#Item CodePackage Description
1NDC:61010-5000-03.3 g in 1 PACKET
2NDC:61010-5000-1121.2 g in 1 BOTTLE
3NDC:61010-5000-30.9 g in 1 POUCH
4NDC:61010-5000-4144 POUCH in 1 CARTON
40.9 g in 1 POUCH
5NDC:61010-5000-525 POUCH in 1 CARTON
50.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2012
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-5000)

Revised: 02/2017
 
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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