BURN- lidocaine hydrochloride spray 
First Aid Only, Inc

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 Ingredients

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 area
  • 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 returns

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

Directions

Inactive ingredients

aloe vera, germaben II. Propylene glycol, purified water

Burn Spray

Pain relieving spray for use on minor burns.

M5082

3 fl. oz. (88.7 ml.)
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FIRST AID ONLY

Distributed by First Aid Only, Inc.

Vancouver, WA 96882 USA

Principal Display Panel
BURN 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62985-5082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 g  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:62985-5082-10.0887 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/2014
Labeler - First Aid Only, Inc (196551634)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(62985-5082)

Revised: 8/2014
Document Id: 6af86da3-ca4f-48f8-86de-483995abc55a
Set id: eaf73161-8597-4575-8b0f-be3e3389e5cc
Version: 2
Effective Time: 20140813
 
First Aid Only, Inc