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Drug Facts
Afassco Burn Gel
FDA Label NDC 51532-3806
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Afassco Burn Gel (NDC 51532-3806). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
lidocaine 2%
Otc - Purpose
Purpose
Pain Reliever
Indications & Usage
Uses
Cools, soothes, relieves pain,
For First Aid Use of minor burns,
scalds, and sunburns.
Warnings
Warnings
For external use only.
Flammable: Keep away from
excessine heat or open flame
Otc - Ask Doctor
Ask a doctor before use if you
have: sensitive skin
Otc - When Using
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
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
If pregnant or breast feeding:
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children:
If accidentally ingested, get
medical help or contact a Poison
Control Center immediately.
Dosage & Administration
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
Inactive ingredients
Water, Menthol, Propylene Glycol,
Triethanolamine, Carbomer,
Aloe Barbadensis Leaf Extract
Package Labeling
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
24 Count Box Label
Packet Label
res
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