Label: MAXIMUM STRENGTH BLUE EMU PAIN RELIEF BLU EMU- trolamine salicylate 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 May 4, 2023

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  • Active ingredient

    Trolamine salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    •
    simple backache
    •
    arthritis
    •
    strains
    •
    bruises and sprains
  • Warnings

    For external use only

    Allergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    •
    use only as directed
    •
    do not bandage tightly or use with a heating pad
    •
    avoid contact with eyes or mucous membranes
    •
    do not apply to wounds or damaged skin.

    Stop use and ask a doctor if

    •
    condition worsens
    •
    symptoms persist for more than 7 days or clear up and occur again within a few days
    •
    redness is present
    •
    irritation develops.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 12 years:

    •
    apply generously to affected area
    •
    massage into painful area until thoroughly absorbed into skin
    •
    repeat as necessary, but no more than 4 times daily

    children 12 years or younger: ask a doctor.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Dimethyl Sulfone, Disodium EDTA, Emu Oil, Ethylhexylglycerin, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Lecithin, Oleic Acid, Panthenol, Phenoxyethanol, Polysorbate 20, Sorbitol, Water, Xanthan Gum.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    NFI CONSUMER PRODUCTS
    501 Fifth Street • Bristol, TN 37620
    TOLL FREE: 1-800-432-9334
    WWW.BLUE-EMU.COM

  • PRINCIPAL DISPLAY PANEL - 118 ml Can Label

    ANY DIRECTION PAIN
    RELIEF SPRAY
     
    BLUE-EMU®
     
    Continuous
    Spray
     
    AMERICA'S
    #1
    EMU OIL FORMULA
    ODOR
    FREE
     
    Contains Emu Oil
    NET WT 4 OZ (118ml)

    image-01
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH BLUE EMU PAIN RELIEF  BLU EMU
    trolamine salicylate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trolamine Salicylate (UNII: H8O4040BHD) (Salicylic Acid - UNII:O414PZ4LPZ) Trolamine Salicylate10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Emu Oil (UNII: 344821WD61)  
    Glucosamine Sulfate (UNII: 1FW7WLR731)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    Panthenol (UNII: WV9CM0O67Z)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69993-100-04118 mL in 1 CAN; Type 0: Not a Combination Product06/04/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/04/2012
    Labeler - NFI, LLC (121681919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulated Solutions, LLC143266687MANUFACTURE(69993-100)
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