FDA Label for Afassco Burn Gel

View Indications, Usage & Precautions

Afassco Burn Gel Product Label

The following document was submitted to the FDA by the labeler of this product Afassco Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


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

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