Label: PAIN RELIEF STICK- menthol stick

  • 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 July 2, 2021

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  • Active ingredient

    Menthol 10%

  • Purpose

    Menthol 10%...................Topical analgesic

  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with:

    • arthritis
    • sprains
    • muscle strains
    • bruises
  • Warnings

    For external use only.

    Do not use

    • on wounds, or damaged, broken, or irritated skin
    • with a heating pad

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breastfeeding, 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

    • Use only as directed

    Adults and children over 12 years:

    • apply a thin layer to affected area
    • massage into painful area
    • repeat as necessary, but no more than 3 to 4 times daily
    • Children 12 years or younger: ask a doctor.
  • Other information

    • store in a cool, dry place
  • Inactive ingredients

    Capric/Caprytic Triglyceride, Ethylhexyt Patmttate, Candelilla (Euphorbia Cerifera) WaJI., Coconut (Cocos Nucifera) Oil, Camphor, Lavender (Lavanduta Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Kokum (Garcinia tndica) Butter, Mango (Mangffera tndica) Seed Butter, Avocado (Persea Gratissima) Oil, Boswellia Serrata Resin Extract, Amica Montana (Flower) Extract, Magnesium Chloride

  • PRINCIPAL DISPLAY PANEL

    Sagely Naturals

    Pain Relief Stick

    Instant Cooling

    With 10% Menthol

    95% Natural Ingredients

    1.7 OZ / 50 G

    1

    2

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF STICK 
    menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82075-425-251 in 1 CARTON07/02/2021
    150 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/2021
    Labeler - Sagely Enterprises Inc. (117049032)
    Establishment
    NameAddressID/FEIBusiness Operations
    Verde Cosmetic Labs, LLC080656433manufacture(82075-425)
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