Label: 1168- 1168 burn spray spray

  • NDC Code(s): 67777-013-05, 67777-013-06
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • Active Ingredient

    Lidocaine Hydrochloride 2%

  • Purpose

    Topical Analgesic

  • Use(s)

    For the temporary relief of pain associated with minor burns

  • Warnings

    For External Use Only

    Do not use

    • Over large areas of the body, particularly over raw surfaces, or blistered areas

    • Near eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.

    • Children under 12 years of age: Consult a doctor before use

  • Other Information

    • Store at 20º-25ºC (68º-77°F)

  • Inactive Ingredients

    Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

  • Questions?

    1-888-Dynarex Monday - Friday, 9AM - 5PM EST

  • Label

    1168_IN_MASTER1168 Label

  • INGREDIENTS AND APPEARANCE
    1168 
    1168 burn spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.02 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-013-0524 in 1 CASE02/29/2024
    1NDC:67777-013-0659.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/29/2024
    Labeler - Dynarex Corporation (008124539)
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