Label at a glance#

ProductBurn Relief Aloe Vera Gel GNP

Active ingredientLIDOCAINE

Label structure8 sections

Indications and uses

For the temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Dosage and administration

• Adults and children 2 years and older: apply to affected area not more than 3 - 4 times a day. • Children under 2 years of age: consult a physician.

Contacts and useful links#

PhoneLabel contact888-793-8450

Label contents#

Full prescribing information#

Active ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5% ............. External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Warnings For external use only.

WARNINGS SECTION

When using this product: • avoid contact with eyes. Rinse with water if contact occurs.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask doctor if • symptoms persist for more than 7 days, or clear up and occur again within a few days

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years and older: apply to affected area not more than 3 - 4 times a day.
• Children under 2 years of age: consult a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, lsopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

Questions or comments?

OTC - QUESTIONS SECTION

888-793-8450

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1011849	Lidocaine (Topical)	lidocaine hydrochloride 0.005 MG/MG Topical Gel	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46122-654-34	2025-12-09	C162847	48780-1	1030e365-0ec1-111a-e063-dadaa90a10e2	Burn Relief Aloe Gel [GNP]
46122-654-34	2024-01-30	C162847	48780-1	1030e365-0ec1-111a-e063-dadaa90a10e2	Burn Relief Aloe Gel [GNP]

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-654	BURN RELIEF ALOE VERA GEL GNP (LIDOCAINE HL) GEL [AMERISOURCE BERGEN]	3	Legacy NDC	20220118_a98a9a80-227c-45bf-8004-44575006db2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-654-34	ML - Milliliter	46122-654	38990365-f8c7-4ce9-83d7-bc35a0ef2f64	1	2023-02-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Burn Relief Aloe Vera Gel GNP
Lidocaine Hl
ALOE
CARBOMER 940
DIAZOLIDINYL UREA
EDETATE DISODIUM
GLYCERIN
ISOPROPYL ALCOHOL
MENTHOL
POLYSORBATE 80
PROPYLENE GLYCOL
TROLAMINE
WATER
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46122-654	46122-654-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE	V5VD430YW9	IACT
CARBOMER 940	4Q93RCW27E	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MENTHOL	L7T10EIP3A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
LIDOCAINE	98PI200987	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
458587ff-00ee-2ba9-e063-6294a90a2dc7			a98a9a80-227c-45bf-8004-44575006db2f	2025-12-09	Warnings	Exact identifier spl set id: a98a9a80-227c-45bf-8004-44575006db2f

Reported adverse events (FAERS/openFDA)#

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

Burn Relief Aloe Vera Gel