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

  • 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 25, 2023

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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
    WWW.BLUE-EMU.COM

  • PRINCIPAL DISPLAY PANEL - 88 g Tube Carton Label

    ULTRA

    BLUE-EMU®
    -HEMP-

    CANNABIS SATIVA
    SEED OIL + EMU OIL

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

    PRINCIPAL DISPLAY PANEL - 88 g Tube Carton
  • 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 (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 not finalpart34804/05/2021
    Labeler - NFI, LLC (121681919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals081301372MANUFACTURE(69993-200)
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