Your browser does not support JavaScript! LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

LIDOCAINE HYDROCHLORIDE gel
[Acme United Corporation]


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

Drug Facts

Active ingredients

Lidocaine HCl 2%

Purpose

Topical pain relief

Uses

Temporary pain relief of minor burns. For professional use only.

Warnings

For external use only. Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly

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

  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Other information

  • store at room temperature (do not freeze)
  • do not use any opened or torn packs

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL – 6 count box

Pac-Kit
First Aid

Burn Gel
Packets

Paquetes de gel
para quemaduras

6 Burn Gel
Packets,
3.5g ea

6 paquetes,
3.5g cada uno

Reorder no. 13-010

ANSI Z308.1-2009

PRINCIPAL DISPLAY PANEL – 6 count box

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

Physicians Care

Burn Gel

For Temporary
Pain Relief of
Minor Burns

0.125 oz. (3.7 ml)
Reorder no. 13010

Distributed by
Acme United Corporation
Fairfield, CT 06824
800-835-2263
www.PhysiciansCareFirstAid.com

PRINCIPAL DISPLAY PANEL – 0.125 oz. packet
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0924-5000
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:0924-5000-016 in 1 BOX
13.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/14/2013
Labeler - Acme United Corporation (001180207)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0924-5000)

Revised: 2/2013
 
Acme United Corporation

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services