DYNAREX BURN CREAM- lidocaine cream 
Dynarex Corporation

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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Dynarex Burn Cream

Active Ingredients

Active Ingredient                                       Purpose

Lidocaine HCL 0.5%                                   Topical Analgesic

Benzalkonium Chloride 0.13%                    Topical Antiseptic

Purpose

Temporary relief of pain and itching.

Uses

For temporary relief of pain and itching associated with:

Warnings

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use

Stop Use and ask a doctor:

Do Not Use

Do Not Use:

Directions

Adults and children 2 years and over:

Children under 2 years

Inactive ingredients

Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

Other Information

Other Information

Principal Display Panel

Dynarex Burn Cream 

DFAC.jpg

Burn Cream

DYNAREX BURN CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETETH-20 (UNII: I835H2IHHX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-412-010.9 g in 1 PACKET; Type 0: Not a Combination Product09/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2015
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-412)

Revised: 4/2016
Document Id: f24d37cd-5b6d-4b78-8821-92d3ea4afd35
Set id: b3fe8c85-03cd-44d9-8c28-edb9c05a8115
Version: 4
Effective Time: 20160411
 
Dynarex Corporation