BURN- lidocaine hydrochloride gel 
Yiwu Ori-Power Medtech Co., Ltd.

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 Hydrochloride 2%

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 the 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

Inactive ingredients

Aloe BarbadensisLeaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

image of pouch label

BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72459-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72459-101-010.9 g in 1 POUCH; Type 0: Not a Combination Product08/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/28/2023
Labeler - Yiwu Ori-Power Medtech Co., Ltd. (560451976)

Revised: 8/2023
Document Id: 03f3c281-542c-6fca-e063-6394a90abec5
Set id: 03f3c281-542b-6fca-e063-6394a90abec5
Version: 1
Effective Time: 20230827
 
Yiwu Ori-Power Medtech Co., Ltd.