Label: CANNESSENTIA PAIN RELIEF CREAM- 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 December 18, 2019

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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
    • 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. Read and follow all directions and warnings on this label
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • 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 as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last 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 not more than 3to 4 times daily

    children 12 years and younger: ask a doctor

  • Inactive ingredients

    coconut oil, cod liver oil (contains vitamin A & vitamin D), fragrances, hemp seed oil, lanolin, light mineral oil, medium-chain triglycerides, microcrystalline wax, paraffin, petrolatum, sodium chloride, terpene essential oil, yellow wax

  • Principal Display Panel

    NDC # 72418-333-15

    CannEssentia

    Pain Relief Cream

    (Trolamine Salicylate)

    NET WT 0.5 OZ (14.17 g)

    box

  • INGREDIENTS AND APPEARANCE
    CANNESSENTIA PAIN RELIEF CREAM 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72418-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72418-333-151 in 1 CARTON03/01/2019
    114.17 g in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2019
    Labeler - CannEssentia LLC (031775148)
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