AFASSCO BURN GEL- lidocaine gel

Afassco Burn Gel by

Drug Labeling and Warnings

Afassco Burn Gel by is a Otc medication manufactured, distributed, or labeled by Afassco Inc., Yuyao Jessie Commodity Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

lidocaine 2%

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

ASK DOCTOR

Ask a doctor before use if you

have: sensitive skin

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

STOP USE

Slop use and & a doctor if:

Condition worsens, or if

symptoms persist for more than

7 days, or clear up and recur.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding:

Ask a health professional before use.

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

INGREDIENTS AND APPEARANCE

AFASSCO BURN GEL 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-3806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	70 mg  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 1342 (UNII: 809Y72KV36)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-3806-1	6 in 1 BOX	08/25/2019
1		3.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 51532-3806-2	24 in 1 BOX	08/25/2019
2		3.5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/25/2019

Labeler - Afassco Inc. (609982723)

Registrant - Afassco Inc. (956159800)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co., Ltd.		529892305	manufacture(51532-3806)