Label: BLUE-EMU ULTRA WITH HEMP SEED- trolamine salicylate cream

  • NDC Code(s): 69993-200-03
  • Packager: Kingsway Pharmaceuticals dba NFI, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • Active Ingredient

    Trolamine salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

    •
    arthritis
    •
    simple backache
    •
    muscle strains
    •
    sprains
    •
    bruises
    •
    cramps
  • 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 of age:

    •
    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.

  • Other information

    Store at 68-77°F (20-25°C)

  • Inactive ingredients

    acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), cannabis sativa seed oil, cetyl alcohol, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine HCl, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopheryl acetate (Vitamin E), water.

  • SPL UNCLASSIFIED SECTION

     
    DISTRIBUTED BY: NFI CONSUMER PRODUCTS
    501 Fifth Street • Bristol, TN 37620 • 1-800-432-9334

  • PRINCIPAL DISPLAY PANEL – Carton Label

    PAIN RELIEF
    ULTRA
     

    BLUE-EMU®
    -HEMP-

    CANNABIS SATIVA
    SEED OIL + EMU OIL
     

    TOPICAL PAIN RELIEF CREAM
    NET WT 3 OZ. (88g)

    image-01
  • INGREDIENTS AND APPEARANCE
    BLUE-EMU ULTRA WITH HEMP SEED 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69993-200-031 in 1 CARTON04/05/2021
    188 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/05/2021
    Labeler - Kingsway Pharmaceuticals dba NFI, LLC (121681919)
    Registrant - Kingsway Pharmaceuticals dba NFI, LLC (121681919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals081301372MANUFACTURE(69993-200)
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