EPIC Burn Cream

Manufacturer
Epic Medical Supply Corp | ASTONEA LABS PRIVATE LIMITED
Effective date
2023-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:31:23

Label at a glance#

ProductEPIC Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 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 or 4 times daily. may be covered with a sterile bandage Children under 2 years consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Antiseptic

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

Do Not Use

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.

Stop Use

OTC - STOP USE SECTION

•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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 or 4 times daily.
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

•store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

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
82749-10082749-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
fbd2a10d-e1d4-01ab-e053-6294a90a063cfbd2adb0-ed30-4c0f-e053-6294a90a76c42023-05-16WarningsExact identifier
spl id: fbd2a10d-e1d4-01ab-e053-6294a90a063c
spl set id: fbd2adb0-ed30-4c0f-e053-6294a90a76c4

Reported adverse events (FAERS/openFDA)#

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