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First Aid and Burn (Safetec of America, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 144 PACKET in 1 BOX (61010-5701-4) > .9 g in 1 PACKET (61010-5701-3) Label Information
CREAM 25 PACKET in 1 BOX (61010-5701-5) > .9 g in 1 PACKET (61010-5701-3) Label Information

Complete First Aid and Burn Information

  • 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

  • INGREDIENTS AND APPEARANCE
    FIRST AID AND BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-5701
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride 1.3 mg  in 1 g
    lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61010-5701-4 144 in 1 BOX 09/21/2012
    1 NDC:61010-5701-3 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:61010-5701-5 25 in 1 BOX 09/21/2012
    2 NDC:61010-5701-3 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/21/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(61010-5701)