Label: AFASSCO BURN GEL- lidocaine gel

  • NDC Code(s): 51532-3806-1, 51532-3806-2
  • Packager: Afassco Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 12, 2023

If you are a consumer or patient please visit this version.

  • 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

    BurGel 388 6ctBox

    24 Count Box Label

    BurGelAloe 38006 24ctBox

     Packet Label

    BurGelAloe Packet

    res

  • INGREDIENTS AND APPEARANCE
    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)