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Burn with Aloe

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)

Revised: 07/2014
 
Provision Medical

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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