BURN WITH ALOE- lidocaine hydrochloride spray 
Provision Medical

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

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

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

Principal Display Panel - Bottle Label
BURN WITH ALOE 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous200 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-3500-10.05915 L in 1 BOTTLE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-3500)

Revised: 7/2014
Document Id: ee784266-bfe1-4518-b47e-7224dc58b834
Set id: 2a08a5af-7146-433b-9874-1e5f66c2c3a8
Version: 1
Effective Time: 20140724
 
Provision Medical