Afassco Burn Gel

Afassco Burn Gel
SPL v2
SPL
SPL Set ID a3089a13-1bf8-405f-9926-fb56dff3a823
Route
TOPICAL
Published
Effective Date 2023-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (70 mg)
Inactive Ingredients
Water Menthol Propylene Glycol Trolamine Carbomer 1342 Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-25

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable: Keep away from

excessine heat or open flame

Indications and Usage

Uses

Cools, soothes, relieves pain,

For First Aid Use of minor burns,

scalds, and sunburns.

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children:

If accidentally ingested, get

medical help or contact a Poison

Control Center immediately.

Section 50566-9

Slop use and & a doctor if:

Condition worsens, or if

symptoms persist for more than

7 days, or clear up and recur.

Section 50567-7

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

Section 50569-3

Ask a doctor before use if you

have: sensitive skin

Section 51727-6

Inactive ingredients

Water, Menthol, Propylene Glycol,

Triethanolamine, Carbomer,

Aloe Barbadensis Leaf Extract

Section 53414-9

If pregnant or breast feeding:

Ask a health professional before use.

Section 55105-1

Purpose

Pain Reliever

Section 55106-9

Active ingredient

lidocaine 2%

Section 60561-8

Other information

Store sealed packet in a cool dry place

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 GEL WITH 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


Structured Label Content

Indications and Usage (34067-9)

Uses

Cools, soothes, relieves pain,

For First Aid Use of minor burns,

scalds, and sunburns.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable: Keep away from

excessine heat or open flame

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children:

If accidentally ingested, get

medical help or contact a Poison

Control Center immediately.

Section 50566-9 (50566-9)

Slop use and & a doctor if:

Condition worsens, or if

symptoms persist for more than

7 days, or clear up and recur.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you

have: sensitive skin

Section 51727-6 (51727-6)

Inactive ingredients

Water, Menthol, Propylene Glycol,

Triethanolamine, Carbomer,

Aloe Barbadensis Leaf Extract

Section 53414-9 (53414-9)

If pregnant or breast feeding:

Ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain Reliever

Section 55106-9 (55106-9)

Active ingredient

lidocaine 2%

Section 60561-8 (60561-8)

Other information

Store sealed packet in a cool dry place

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 GEL WITH 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


Advanced Ingredient Data


Raw Label Data

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