Label: FIRE OUT- benzocaine and menthol solution

  • NDC Code(s): 52412-300-10, 52412-300-20
  • Packager: Randob Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2019

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  • Active ingredient

    Benzocaine USP 20%

    Menthol USP 1%

  • Purpose

    (for pain) Topical Anesthetic

    (anti-itch) Antipruritic

  • Keep Out of Reach of Children

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

  • Uses

    ▪
    Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.
  • Warnings

    ▪
    For external use only
    ▪
    Do not apply over large areas of the body
    ▪
    Avoid contact with eyes, mouth, and mucous membranes
  • Directions

    Children under 2 yrs.

    ▪
    Do not use
    ▪
    Consult doctor

    Adults and children 2 yrs. and older

    ▪
    Clean area
    ▪
    Apply to affected area as needed not more than 3 to 4 times a day.
  • Inactive Ingredients

    FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water.

  • Package/Label Principal Display Panel

    NEW!

    KILLS THE PAIN

    STOPS THE ITCH

    FIRE OUT™

    INSTANT PAIN RELIEF

    from:

    Fire Ant Stings

    also from:

     
    Mosquito Bites Insect Bites
     
    Jellyfish Stings Bee Stings

    MAXIMUM STRENGTH

    PAIN RELIEVING LIQUID

    NO-MESS ROLL-ON

    1.7 fl oz (50 ml)

    MADE IN THE USA

    DUAL ACTION

    carton-label-bottle
  • INGREDIENTS AND APPEARANCE
    FIRE OUT 
    benzocaine and menthol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUE (Blue) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-300-101 in 1 CARTON02/15/2016
    150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:52412-300-205 in 1 BLISTER PACK03/15/201703/15/2017
    20.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2016
    Labeler - Randob Ltd. (061995007)
    Registrant - Randob Ltd. (061995007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Multi-Pack Solutions557434805ANALYSIS(52412-300) , MANUFACTURE(52412-300) , PACK(52412-300) , LABEL(52412-300)
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