Label: FIRST AID AND BURN- benzalkonium chloride, lidocaine hydrochloride cream

  • NDC Code(s): 61010-5701-3, 61010-5701-4, 61010-5701-5, 61010-5701-6
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    • temporary relief of pain associated with minor burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
    • for more than one week unless directed by a doctor

    Keep out of reach of children.

    If ingested contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • children under 2: consult a doctor
  • Inactive ingredients

    aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

  • PRINCIPAL DISPLAY PANEL – 0.9 gram packet

    NDC 61010-5701-03

    Safetec

    First Aid &
    Burn Cream

    0.9 g (1/32 oz.)

    Safetec of America, Inc.
    Buffalo, NY 14215
    800-456-7077

    PRINCIPAL DISPLAY PANEL – 0.9 gram packet
  • PRINCIPAL DISPLAY PANEL – 144 count box

    NDC 61010-5701-4

    Safetec

    First Aid

    First Aid & Burn Cream

    • For Temporary Relief of
      Pain Associated with
      Minor Burns
    • Helps Protect Against
      Harmful Bacteria

    Reorder No. 53410
    To reorder:
    Call: 1-800-456-7077
    Fax: 716-895-2969
    Online: www.safetec.com

    PRINCIPAL DISPLAY PANEL – 144 count box
  • Principal Display Panel – 10 Packet Box Label

    Safetec ®

    FIRST AID

    Burn Cream

    Quickly soothes pain caused by minor burns
    and protects against infection

    10 Packets

    Each Packet Net. Wt. 0.9g

    Made in USA

    Reorder No. 53408

    Principal Display Panel – 10 Packet Box Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID AND BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5701-4144 in 1 BOX09/21/2012
    1NDC:61010-5701-30.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:61010-5701-525 in 1 BOX09/21/2012
    2NDC:61010-5701-30.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:61010-5701-610 in 1 BOX04/01/2020
    3NDC:61010-5701-30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/21/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5701)
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