DYNAREX BURN CREAM- lidocaine cream

Dynarex Burn Cream by

Drug Labeling and Warnings

Dynarex Burn Cream by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Galentic Pharma (India) Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Sunburn
• Minor burns,
• Insect bites,
• Minor skin irritation,
• Cuts and 
• Scrapes

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:

• If condition worsens or,
• if symptoms persist for more than 7 days or clear up and occur again in a few days.
• If pregnant or breast feeding, ask a health professional before use.

Do Not Use

Do Not Use:

• In the eyes
• Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
• In large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children 2 years and over:

• clean the affected area
• apply a small amount of this product on the area 3 or 4 times daily.
• may be covered with a sterile bandage

Children under 2 years

• consult a doctor

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

• store in a cool, dry area
• 59o to 79o F (15o to 25o C)
• Tamper evident sealed packets do not use any open or torn packets

Principal Display Panel

Dynarex Burn Cream 

DFAC.jpg

INGREDIENTS AND APPEARANCE

DYNAREX BURN CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-412-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	09/16/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2015

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Pvt. Ltd.		650970176	manufacture(67777-412)