Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• Active Ingredients

  Benzalkonium Chloride 0.13%

  Lidocaine HCl 0.5%

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• Purpose

  First Aid Antiseptic

  Topical Analgesic

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• Uses

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

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• 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.

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• Directions

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

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• Inactive ingredients

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

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• 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

  

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• 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

  

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• 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)

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