Label: BURN FIRST AID cream

  • NDC Code(s): 67777-007-49, 67777-007-50, 67777-007-51, 67777-007-52, view more
    67777-007-53, 67777-007-54
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • Active Ingredient

    Lidocaine HCl 0.5%

  • Purpose

    Topical analgesic

  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Topical antiseptic

  • Uses

    For the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, scrapes

  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    • the condition gets worse
    • condition clears up and recurs within a few days
    • condition persists for more than 7 days

    If pregnant or breast feeding,

    ask a health care professional before use.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and over:

    • clean the affected area
    • apply a small amount of this product on the area 3 to 4 times daily
    • may be covered with a sterile bandage

    Children under 2 years:

    • consult a doctor
  • Other Information

    • store in a cool, dry area 15°-25° C (59°-79° F)
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Inactive Ingredients

    Butylated Hydroxytoluene, Cetomacrogol, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

  • 1165 Label

    1165 First Aid Burn Cream

  • 1165UB-10 Label

    1165UB-10_BX_MASTER1165UB-10

  • 1165UB-25 Label

    1165UB-25_BX_MASTER

  • INGREDIENTS AND APPEARANCE
    BURN FIRST AID 
    burn first aid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS50 mg  in 10000 mg
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10000 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    CETETH-20 (UNII: I835H2IHHX)  
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-007-501728 in 1 CASE09/17/2018
    1NDC:67777-007-49144 in 1 BOX
    1900 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-007-521000 in 1 CASE09/17/2018
    2NDC:67777-007-5110 in 1 BOX
    2900 mg in 1 PACKET; Type 0: Not a Combination Product
    3NDC:67777-007-541800 in 1 CASE09/17/2018
    3NDC:67777-007-5325 in 1 BOX
    3900 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/17/2018
    Labeler - Dynarex Corporation (008124539)
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