BURN- lidocaine hydrochloride and benzalkonium chloride cream

Burn by

Drug Labeling and Warnings

Burn by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

PURPOSE

Topical antiseptic

Topical analgesic

USES

• For temporary relief of pain and itching associated with:
  • sunburn
  • minor burns
  • insect bites
  • minor skin irritation
  • cuts
  • scrapes

WARNINGS

For external use only.

• 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

• Stop use and ask a doctor if
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
  • if pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children.

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

DIRECTIONS

Adults and children 2 years and over:

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

Children under 2 years

• consult a doctor

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Butylated hydroxytoluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Sodium EDTA, Sodium methylparaben, Sodium propylparaben, Purified Water

SPL UNCLASSIFIED SECTION

Manufactured by :

Galentic Pharma (India) Pvt. Ltd.,

Plot No. 5-B & 5-C, Sector III,

Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL - 0.9 gram Packet Carton

NDC # 50382-022-12

GALENTIC
Burn Cream with Lidocaine

Antiseptic and pain relieving cream
for minor cuts, scrapes and burns

0.9 gram Packets
25 per box

INGREDIENTS AND APPEARANCE

BURN 
lidocaine hydrochloride and benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-022-11	10 in 1 CARTON	04/14/2016
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50382-022-12	25 in 1 CARTON	04/14/2016
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50382-022-13	144 in 1 CARTON	09/01/2015
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product

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

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-022) , manufacture(50382-022) , pack(50382-022) , repack(50382-022) , sterilize(50382-022)