Afassco Burn Gel

Manufacturer
Afassco Inc. | Yuyao Jessie Commodity Co., Ltd.
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:14

Label at a glance#

ProductAfassco Burn Gel
Active ingredientLIDOCAINE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

lidocaine 2%

OTC - PURPOSE SECTION

Purpose

Pain Reliever

INDICATIONS & USAGE SECTION

Uses

Cools, soothes, relieves pain,

For First Aid Use of minor burns,

scalds, and sunburns.

WARNINGS SECTION

Warnings

For external use only.

Flammable: Keep away from

excessine heat or open flame

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

have: sensitive skin

OTC - WHEN USING SECTION

When using this product: Avoid

contact with eyes and mucos

membranes ● Do not apply to

wounds or damaged skin  ● Do

not apply to irritated skin

or if excessive irritation develops

● Do not bandage  ● Wash hands

after use with cool water  ● Do

not use with heating pad or device

OTC - STOP USE SECTION

Slop use and & a doctor if:

Condition worsens, or if

symptoms persist for more than

7 days, or clear up and recur.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding:

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:

If accidentally ingested, get

medical help or contact a Poison

Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

● Adults & children over 2 years

of age:  Rub a thin film over

affected areas no more than 4

times a day - massage not

necessary ● Children under 2

years of age: Consult a physician

OTHER SAFETY INFORMATION

Other information

Store sealed packet in a cool dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Menthol, Propylene Glycol,

Triethanolamine, Carbomer,

Aloe Barbadensis Leaf Extract

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Afassco¦ ¦®

The First Choice

          in First Aid

AFASSCO

BURN GEL WITH ALOE VERA


​FOR FIRST AID USE ON MINOR BURNS, SCALDS, & SUNBURN

No.388                                                                                 6 ct.

AFASSCO

BURN GELWITH ALOE VERA

6 ct.

AFASSCO

BURN GELWITH ALOE VERA

6 ct.

COOLS, SOOTHES, RELIEVES PAIN. FOR FIRST AID USE
ON MINOR BURNS, SCALDS, AND SUNBURN.

INSTRUCTIONS: Apply a generous layer of Burn Gel to the affected area.
Do not rub into skin. The skin should feel cool within 30 minutes.
If the heat persists, reapply as needed. Twice daily use of Burn Gel will
unlock the natural healing power of Aloe Vera to help revitalize the skin.

WARNING: If redness or swelling persists for 7 days or if infection or rash develops,
discontinue use and seek medical advice.

REFRESCA, ALIVIA, SUAVIZA EL DOLOR, PARA UTILIZAR
COMO PRIMEROS AUXILIOS EN PEQUEÑAS
QUEMADURAS, ESCALDADURAS Y QUEMADURAS DEL SOL.

INSTRUCCIONES: Aplique na capa generosa de gel de grabación para la zona
afectada. No se frote en la piel. La piel debe estar frio en 30 minutos. Si el calor
persiste, volver a aplicar según sea necesario. Dos veces el uso diario de gel se
desbloqueará los recursos naturales poder curativo del Aloe Vera para ayudar a
revitalizar la piel.

ADVERTENCIAS: Si el enrojecimiento o la hinchazón persisten durante 7 días o si
desarrolla una infección o erupción cutánea, suspenda su uso y consultar al médico.

INGREDIENTS: Water, Menthol, Propylene Glycol, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract.

Afassco¦ ¦® ANSI Z308.1               Manufactured for Afassco, Inc., Minden, NV 89423

6  70254 20388 7

6 Count Box Label

BurGel 388 6ctBoxBurGel 388 6ctBox

24 Count Box Label

BurGelAloe 38006 24ctBoxBurGelAloe 38006 24ctBox

 Packet Label

BurGelAloe PacketBurGelAloe Packet

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2107764lidocaine 2 % Topical GelPSN2
2107764lidocaine 0.02 MG/MG Topical GelSCD2
2107764lidocaine 2 % Topical GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51532-3806-12024-07-30C16284748780-11e7a6dab-1f35-a2ce-e063-dadaa90aadf7Afassco Burn Gel
51532-3806-22024-07-30C16284748780-11e7a6dab-1f35-a2ce-e063-dadaa90aadf7Afassco Burn Gel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51532-3806AFASSCO BURN GEL (LIDOCAINE) GEL [AFASSCO INC.]2Legacy NDC20230113_a3089a13-1bf8-405f-9926-fb56dff3a823.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51532-380651532-3806-1, 51532-3806-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
20d65482-3be7-4f8a-b18c-c5d9f4ac34c7a3089a13-1bf8-405f-9926-fb56dff3a8232023-01-12WarningsExact identifier
spl id: 20d65482-3be7-4f8a-b18c-c5d9f4ac34c7
spl set id: a3089a13-1bf8-405f-9926-fb56dff3a823

Reported adverse events (FAERS/openFDA)#

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