FDA.reportPublic FDA data

Burn Cream

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2023-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:38:33

Label at a glance#

ProductBurn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

PURPOSE

OTC - PURPOSE SECTION

Topical antiseptic

Topical analgesic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - 0.9 gram Packet Carton
Principal Display Panel - 0.9 gram Packet Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-02250382-022-11, 50382-022-12, 50382-022-13, 50382-022-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLCELLULOSE (25 MPA.S)BI55GG2WLIIACT
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f3a2f68b-6f5e-9180-e053-2a95a90abdfe9abedfe3-52fa-44f5-b489-5c42b80c93482023-02-01WarningsExact identifier
spl id: f3a2f68b-6f5e-9180-e053-2a95a90abdfe
spl set id: 9abedfe3-52fa-44f5-b489-5c42b80c9348

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.