BURN RELIEF- lidocaine spray 
Amerisource Bergen

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                     Purpose
Lidocaine 0.5%.........................External analgesic

Uses

For the temporary relief of pain and itching associated with: • sunburn
• minor burns • minor cuts • scrapes • insect bites • minor skin irritations

Warnings
For external use only.
Flammable: Do not use near heat, flame, or while smoking.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
When using this product • keep away from face to avoid breathing it. • avoid
contact with eyes. • use only as directed. • do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
If condition worsens or if symptoms persist for more than 7 days or clear up and
occur again within a few days, discontinue use of this product and consult a doctor.

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

Directions • Shake well • Adults and children 2 years of age and older: apply
to affected area not more than 3 to 4 times daily • Children under 2 years of age:
consult a doctor • Do not spray directly into face; spray into palm of hand and
gently apply

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl
Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben,
Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate,
Triethanolamine.

Questions? 610-727-7000

image description

BURN RELIEF 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Aloe (UNII: V5VD430YW9)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-777-04128 g in 1 CAN; Type 0: Not a Combination Product03/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2012
Labeler - Amerisource Bergen (007914906)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(24385-777) , label(24385-777)

Revised: 7/2018
Document Id: be6f2378-cd98-4278-8f02-9092a99306f5
Set id: 77072d8c-080d-4a3d-8733-ea25aee765cf
Version: 1
Effective Time: 20180723
 
Amerisource Bergen