FDA.reportPublic FDA data

Rediburn Burn Gel Skin Protectant

Manufacturer
Redicare LLC
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:45:41

Label at a glance#

ProductRediburn Burn Gel Skin Protectant
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

Protects skin from further damage Cools burns Relieves pain & Itching

Dosage and administration

Seek medical advice before applying on extreme burns. Apply generous amount of gel to the skin. Repeat as necessary. Cover/wrap burn area if required.

Label contents#

Full prescribing information#

Active Ingredients.........Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 35mg...........Pain Reliever

Uses

OTC - PURPOSE SECTION

  • Protects skin from further damage
  • Cools burns
  • Relieves pain & Itching

Warnings

WARNINGS SECTION

For External use Only

Do not use

OTC - DO NOT USE SECTION

without medical direction on severe burns that cover more than 10% of the body.

When using this product

OTC - WHEN USING SECTION

take care to replace dressings as often as necessary to prevent sticking to the wound.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation persists or worsens.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Seek medical advice before applying on extreme burns.
  • Apply generous amount of gel to the skin.
  • Repeat as necessary.
  • Cover/wrap burn area if required.

Other information

INDICATIONS & USAGE SECTION

  • Contents sterile until package opened or damaged.
  • Gel can be rinsed off with water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Propylene glycol
  • Glycerine
  • Silicone emulsion
  • carbomer
  • purified water
  • tea tree oil
  • Aloe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURN GELBURN GEL

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-09671105-096-01, 71105-096-02, 71105-096-04, 71105-096-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER 934Z135WT9208IACT

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
c62a2e86-7f5a-45e1-e053-2a95a90af9c44bcdf2c6-dbdf-558f-e054-00144ff8d46c2021-07-02WarningsExact identifier
spl set id: 4bcdf2c6-dbdf-558f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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