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Lidocaine Hydrochloride by Acme United Corporation

Dosage form: gel
Ingredients: Lidocaine Hydrochloride 20mg in 1g
Labeler: Acme United Corporation
NDC Code: 0924-5000

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 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 - Pouch Label

FIRST AID ONLY®

Burn Gel

For Temporary
Pain Relief of
Minor Burns

NET WT 3.5g

Distributed by

© 2016 Acme United Corporation.

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5000
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:0924-5000-016 PACKET in 1 BOX
1NDC:0924-5000-003.5 g in 1 PACKET
2NDC:0924-5000-0225 PACKET in 1 BOX
2NDC:0924-5000-003.5 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/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(0924-5000)

 
Acme United Corporation

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Medically reviewed on Mar 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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