Label: CANNAFLEX- trolamine salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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 16, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Trolamine Salicylate - 10%

  • PURPOSE

    Purpose:

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor pain associated with arthritis, backache, muscle strains, muscle sprains, bruises, cramps. 

  • WARNINGS

    Warning: For external use only.

  • ASK DOCTOR

    Allergy alert if prone to allergic reaction from aspirin or salicylates, consult a Doctor before use.

  • WHEN USING

    When using this product: Use only as directed. Read and follow all directions and warnings on this label. Do not bandage tightly or use with a heated pad. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use at the same time with other topical analgesics.

  • STOP USE

    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 persistent. Irritation develops.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Coconut Alkanes, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Methyl Sulfonyl Methane, Stearic Acid, Glycerin, Aesculus Hippocastannum (Horse Chestnut) Seed Extract, Rosa Moschata Seed Oil, Menthoxypropanediol, Sorbitan Olivate, Cannabidiol (From full spectrum hemp extract), Medium Chain Triglyceride, Cetearyl Olivate, Phenoxyethanol, Menthyl Lactate, Tocopherol, Mentha Piperita (Pepperment) Oil, Cetyl Palmitate, Sorbitan Palmitate, Coco-Caprylate/Caprate, Caprylyl Glycol, Menthol, Xanthan Gum, Ethylhexylglycerin, Hexylene Glycol, Vanillyl Butyl Ether.

  • DOSAGE & ADMINISTRATION

    Adults and Children over 12 years: Apply generously to affected area. Massage into painful area until thoroughly asborbed into skin. Repeat as necessary, But no more than 4 times daily.

  • QUESTIONS

    Questions or Comments? 

    Call our customer service department at: 1-800-898-5153 

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:

    CBD Therapeutics, LLC

    Salt Lake City, UT 84116

    ImageCannaflex

  • INGREDIENTS AND APPEARANCE
    CANNAFLEX 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MENTHOL (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4177-21 in 1 CARTON10/16/2019
    1NDC:62742-4177-145 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/16/2019
    Labeler - ALLURE LABS INC. (926831603)
    Registrant - ALLURE LABS INC. (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALLURE LABS INC.926831603manufacture(62742-4177)