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Burn by First Aid Only, Inc

Dosage form: spray
Ingredients: Lidocaine Hydrochloride 20g in 1L
Labeler: First Aid Only, Inc
NDC Code: 62985-5082

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.

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
  • Adults and children 2 years of age and older; spray an even layer of burn spray over affected area not more than 3-4 times daily
  • For children under 2 years of age, consult a physician.

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

BURN 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62985-5082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous20 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
propylene glycol 
diazolidinyl urea 
water 
Packaging
#Item CodePackage Description
1NDC:62985-5082-10.0887 L in 1 BOTTLE, SPRAY
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/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(62985-5082)

 
First Aid Only, Inc

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Medically reviewed on Aug 13, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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