Label: ANALGESIC- menthol spray

  • 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 October 26, 2011

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  • SPL UNCLASSIFIED SECTION

    OuWee Jones PAIN RELIEF SPRAY

    Pain Spray

    Drug Facts

  • Active Ingredients

    USP Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief of jellyfish stings.

  • Warnings

    For external use only

    Flammable. Keep away from flame.

    Keep out of reach of children. If swallowed get medical help or contact a poison center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

  • Directions

    For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

    Questions or Comments
    855-37-OUWEE or
    www.ouweejones.com

    Distributed By:
    OuWee Jones Co.
    PO Box 118, Mobile, AL 36601
    www.ouweejones.com

  • PRINCIPAL DISPLAY PANEL

    NDC 76417-8200-1

    Ou! Wee!

    Jellyfish Sting Relief

    #1 Recommended Jellyfish Pain Relief Spray

    4 fl. oz. (118 ml)

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76417-8200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol700 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isopropyl alcohol (UNII: ND2M416302)  
    glycerin (UNII: PDC6A3C0OX)  
    eucalyptus oil (UNII: 2R04ONI662)  
    methyl salicylate (UNII: LAV5U5022Y)  
    peppermint oil (UNII: AV092KU4JH)  
    coconut oil (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76417-8200-10.118 L in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/26/2011
    Labeler - Ouwee Jones, LLC (969347462)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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