LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride gel 
Acme United Corporation

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.

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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

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

Principal Display Panel - Pouch Label
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5000
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:0924-5000-016 in 1 BOX02/14/2013
1NDC:0924-5000-003.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5000-0225 in 1 BOX02/14/2013
2NDC:0924-5000-003.5 g in 1 PACKET; Type 0: Not a Combination Product
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: 3/2016
Document Id: 1e0d0fcf-9188-4bc3-8791-aa9226a41a0a
Set id: c20f9d77-2572-4050-8b8c-8337ca67124e
Version: 3
Effective Time: 20160307
 
Acme United Corporation