ECOLAB BURN (LIDOCAINE HCL 2.0%) SPRAY [ECOLAB FOOD SAFETY SPECIALISTS, INC.]

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ECOLAB BURN (LIDOCAINE HCL 2.0%) SPRAY [ECOLAB FOOD SAFETY SPECIALISTS, INC.]
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NDC 71338-138-02
Set ID 4b6addc3-1615-1e33-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager ECOLAB Food Safety Specialists, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Drug Facts

    Active ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief associated with minor burns.

  • Warnings

    For external use only.

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water

    Stop use and ask a doctor if

    condition worsens or persists for more than 7 days or clears up and returns.

  • Keep out of reach of children.

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

  • Directions

    • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
    • not to be used on children under 12 years of age
  • Inactive ingredients

    decolorized aloe vera, germaben II, propylene glycol, purified water

  • Questions or comments?

    1-800-634-7680

  • Ecolab Burn Spray Label

    ECOLAB®

    Burn Spray

    Analgesic

    Reorder # 43

    Relieves pain in minor burns

    Washable.

    2 fl oz (59 mL)

    Burn Spray

  • INGREDIENTS AND APPEARANCE
    ECOLAB BURN 
    lidocaine hcl 2.0% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71338-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71338-138-020.59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2017
    Labeler - ECOLAB Food Safety Specialists, Inc. (618996086)
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