Label: UNCLE BUDS HEMP PAIN RELIEF- trolamine salicylate salve salve

  • 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 March 11, 2021

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  • Active Ingredient

    Trolamine salicylate 10%

  • Purpose

    Topical analgesic

  • Use

    • Temporary relief of minor ached and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly

    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

    Keep out of reach of children

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

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

  • Other Information

    Store at room temperature. Avoid excessive heat.

  • Inactive Ingredients

    Avocado Oil, Cannabis Sative Seed Oil, Canola Oil, Mandarin Oil, PEG-40 Castor Oil, Polysorbate 20, Safflower Oil, Sunflower Oil, Tocopherol, Yellow Wax

  • Questions?

    www.unclebudshemp.com

  • Jar Label

    Jar LabelCarton Label

  • INGREDIENTS AND APPEARANCE
    UNCLE BUDS HEMP PAIN RELIEF 
    trolamine salicylate salve salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72680-012
    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
    MANDARIN OIL (UNII: NJO720F72R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72680-012-011 in 1 CARTON03/11/2021
    157 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/11/2021
    Labeler - CBH International (116834275)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAKA USA Inc .dba Cosmetic Innovations802860515manufacture(72680-012)
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