AFASSCO BURN GEL- lidocaine gel 
Afassco Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Afassco Burn Gel

Drug Facts

Active ingredient

lidocaine 2%

Purpose

Pain Reliever

Uses

Cools, soothes, relieves pain,

For First Aid Use of minor burns,

scalds, and sunburns.

Warnings

For external use only.

Flammable: Keep away from

excessine heat or open flame

Ask a doctor before use if you

have: sensitive skin

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

Slop use and & a doctor if:

Condition worsens, or if

symptoms persist for more than

7 days, or clear up and recur.

If pregnant or breast feeding:

Ask a health professional before use.

Keep out of reach of children:

If accidentally ingested, get

medical help or contact a Poison

Control Center immediately.

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 information

Store sealed packet in a cool dry place

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

BurGel 388 6ctBox

24 Count Box Label

BurGelAloe 38006 24ctBox

 Packet Label

BurGelAloe Packet

res

AFASSCO BURN GEL 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-3806
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE70 mg  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 1342 (UNII: 809Y72KV36)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-3806-16 in 1 BOX08/25/2019
13.5 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:51532-3806-224 in 1 BOX08/25/2019
23.5 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/25/2019
Labeler - Afassco Inc. (609982723)
Registrant - Afassco Inc. (956159800)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co., Ltd.529892305manufacture(51532-3806)

Revised: 8/2019
 
Afassco Inc.