LIDOCAINE- burn relief aerosol, spray 
Topco Associates LLC

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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TopCare Burn Relief Spray

Active Ingredients

Lidocaine 0.5%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with:

  • sunburn
  • minor burns
  • minor cuts
  • insect bites
  • scrapes
  • minor skin irritations

Warnings

For external use only.

Flammable:

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again in a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake can well
  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult a doctor
  • to apply to face, spray in palm of hand and gently apply

Other information

store between 20º and 25ºC (68º and 77ºF)

Inactive ingredients

aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerin, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Questions?

Call 1-888-423-0139

Principal Display Panel

Top Care health

Burn Relief Spray

LIDOCAINE 0.5%

EXTERNAL ANALGESIC

  • Relieves Pain & Itching from Sunburn, Minor Burns & Insect Bites
  • Cools, Moisturizes & Soothes Sunburned Skin

NET WT 4.5 OZ (127 g)

Burn relief spray

LIDOCAINE 
burn relief aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.64 g  in 127 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTANE (UNII: 6LV4FOR43R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPANE (UNII: T75W9911L6)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-031-45127 g in 1 CAN; Type 0: Not a Combination Product01/03/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/2012
Labeler - Topco Associates LLC (006935977)

Revised: 9/2019
Document Id: 933cfae4-e3fd-3353-e053-2a95a90ad279
Set id: 5faa1d39-12ce-4a65-8e53-0c040e914540
Version: 7
Effective Time: 20190923
 
Topco Associates LLC