BURN- lidocaine hydrochloride spray 
Acme United Corp

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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Drug Facts

Active ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

temporary pain relief associated with 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 a doctor if condition worsens or persists for more than 7 days or clears up and returns

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

Directions

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Questions?

call 203-857-5361

Principal Display Panel - Bottle Label

13-040

BURNS

FIRST AID ONLY®

Burn Spray

Pain relieving spray
for use on minor burns

4 fl oz (118.3ml)

Principal Display Panel - Bottle Label
BURN 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0930
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0930-010.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/06/2014
Labeler - Acme United Corp (001180207)
Registrant - Safetec of America, Inc (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc874965262MANUFACTURE(0924-0930)

Revised: 10/2014
Document Id: 0df118d3-6714-45fc-ac6c-2744fe4669ad
Set id: ce9f2aff-6b2a-4193-8046-dac0af0bb5f1
Version: 3
Effective Time: 20141006
 
Acme United Corp