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Burn with Aloe

Medically reviewed on July 24, 2018

Dosage form: spray
Ingredients: Lidocaine Hydrochloride 200g in 1L
Labeler: Provision Medical
NDC Code: 69103-3500

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 ingredient

Lidocaine HCI 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
  • adults and children 2 years of age and older: spray an even layer of burn spray over cleaned 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

Principal Display Panel - Bottle Label

with aloe vera

BURN SPRAY

Relieves Pain in Minor Burns

Washable

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

BURN WITH ALOE 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous200 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
propylene glycol 
propylparaben 
methylparaben 
diazolidinyl urea 
water 
Packaging
#Item CodePackage Description
1NDC:69103-3500-10.05915 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/29/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(69103-3500)

 
Provision Medical

Further information

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

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