PARAID BURN- lidocaine hydrochloride gel 
Mcure Health Solutions Inc.

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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Paraid Burn Gel

Drug Facts

Active Ingredient

Lidocaine HCL 2.0%

Purpose

Topical Pain Relief

Uses

  • Temporary pain relief for minor burns

Warnings

For external use only.

Keep out of reach of children

Do not use

  • near eyes, if this happens, rinse thoroughly with water
  • in large quantities, particularly over raw or blistered areas.

Stop use, ask a doctor

  • if condition worsens or lasts more than 7 days or clears up and returns. If ingested, contact a poison control center directly.

Directions

  • Adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • Children under 2: do not use, consult with a doctor

Inactive Ingredients

Aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

Package Labeling:

image description

PARAID BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52486-006-011 in 1 CARTON12/25/201512/25/2015
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/25/201512/25/2015
Labeler - Mcure Health Solutions Inc. (053034873)

Revised: 5/2017
Document Id: 4e781310-4fbb-2c49-e054-00144ff8d46c
Set id: 54404754-fc6b-4e07-b399-f9091ab22f1a
Version: 3
Effective Time: 20170501
 
Mcure Health Solutions Inc.