Your browser does not support JavaScript! LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]
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LIDOCAINE HYDROCHLORIDE gel
[Safetec of America, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 – 0.125 oz. packet

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 – 4 oz. bottle
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61010-5000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
propylene glycol 
diazolidinyl urea 
water 
menthol 
.alpha.-tocopherol acetate 
trolamine 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-5000-03.3 g in 1 PACKET
2NDC:61010-5000-1121.2 g in 1 BOTTLE
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/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(61010-5000)

Revised: 10/2012
 
Safetec of America, Inc.

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