Label: CBD 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 17, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Trolamine Salicylate 10%

  • PURPOSE

    Purpose:

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: For temporary relief of minor aches and pains of the muscles and joints (such as arthritis, backache, sprains and bruises).

  • WARNINGS

    Warnings:

    • For external use only
    • Keep out of reach of children
  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact eith eyes or mucus membranes
    • do not apply to wounds or damaged skin
  • STOP USE

    Stop use and ask a doctor if:

    • Condition worsens
    • symptoms persists for more tham 7 days or clear up and occurs again within few days.
    • Redness is present
    • irritaiotn develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breat feeding

    Ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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

  • ASK DOCTOR

    Children 12 years or younger:
    • Ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information
    • Store at room temperature

    ALLERGY ALERT - If prone to allergic reaction from aspirin orsalicylates, consult a doctor before use.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Coconut Alkanes*, Sorbitan Olivate*, Cetearyl Olivate*, Glycerin*, Dimethyl Sulfone, Glyceryl Stearate*,Cannabidiol (From Hemp Extract), Stearic Acid*, Cetyl Palmitate*, Rosa Moschata Seed Oil*, Cetearyl Alcohol, Ceteareth-20, Sorbitan Palmitate*, Tocopherol, Vanillyl Butyl Ether, Coco-Caprylate/Caprate*, Caprylhydroxamic acid*, Glyceryl Caprylate*, Xanthan Gum*

  • PRINCIPAL DISPLAY PANEL

    Manufactured for

    DermaQuest®, Inc.

    Hayward CA-94544

    Made In USA

    dermaquestinc.com

    IMGCBDPRC

  • INGREDIENTS AND APPEARANCE
    CBD PAIN RELIEF CREAM 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4198
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4198-157 g in 1 TUBE; Type 0: Not a Combination Product12/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/17/2020
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc. (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4198)
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