Label: AFASSCO FIRST AID BURN CREAM- lidocaine hydrochloride, benzalkonium chloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 9, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride  0.13%
    Lidocaine HCL   0.5%

  • PURPOSE

    Purpose  First aid antiseptic., external amalgesic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent
    infection and for the
    temporary relief of pain and
    itching associated with minor
    cuts, scrapes, burns

  • WARNINGS

    Warnings

    For external use only

    Do not use ■ in eyes ■ in

    large quantities, over raw

    blistered areas, on deep

    puncture wounds, animal

    bites or serious burns ■ for

    more than one wek

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If ingested, contact a  Poison

    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions 

    ■ clean affected area ■ apply

    a small amount on area, not

    more than 3 times daily

    ■ may cover with a sterile bandage

  • OTHER SAFETY INFORMATION

    Other Information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Peregal-O 2.5%, Glycerin

    Monostearate 2.5%, Glycerol

    5%, Purified Water

  • PRINCIPAL DISPLAY PANEL

    ↓Principal Display 6 ct. Package↓

    Afassco¦ ¦®

    The First Choice

    in First Aid

    FIRST AID/BURN CREAM

    No.339              6 ct.

    6 ct.

    FIRST AID/
    BURN CREAM

    ANSI Z308.1

    Manufactured for Afassco, Inc., Minden, NV 89423

    6 70254 20339 9

    First Aid Burn Crm Box 6ct

    ↓Principal Display 25 ct. Package↓

    First Aid Burn Crm Box 25ct

    ↓1 gm Packet↓

    First Aid Burn Crm 1gm

    res

  • INGREDIENTS AND APPEARANCE
    AFASSCO FIRST AID BURN CREAM 
    lidocaine hydrochloride, benzalkonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-4622
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-4622-16 in 1 BOX12/07/2018
    11 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51532-4622-225 in 1 BOX12/07/2018
    21 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/07/2018
    Labeler - Afassco Inc. (609982723)
    Registrant - Afassco Inc. (956159800)
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