Label: PAIN RELIEF ROLL-ON- menthol liquid

  • 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 November 19, 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.
  • Inactive ingredients

    Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Diheptyl Succinate, Glycerin, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Cellulose Gum, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Boswellia Serrata Resin Extract, Polyglyceryl-6 Caprylate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Cocoate, Polyglyceryl-6 Ricinoleate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Camphor, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Lavender (Lavandula Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid

  • PRINCIPAL DISPLAY PANEL

    Sagely Naturals

    Pain Relief Roll-On

    Instant Cooling

    With 10% Menthol

    95% Natural Ingredients

    2 FL OZ / 60 ML

    1

    2

    1

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF ROLL-ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-420
    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
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)  
    POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
    POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82075-420-201 in 1 CARTON07/02/2021
    160 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:82075-420-051 in 1 CARTON11/19/2021
    251 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(82075-420)
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