Label: PAIN RELIEF CREAM- menthol 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 November 19, 2021

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  • Active ingredient

    Menthol 5%

  • Purpose

    Menthol 5%.................Topical analgesic

  • Uses

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

    • strains
    • bruises
    • simple backache
    • arthritis
    • sprains
  • 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 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 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • Children under 12 years of age: ask a doctor
  • Inactive ingredients

    Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    Sagely Naturals

    Pain Relief Cream

    Instant Cooling

    With 5% Menthol

    95% Natural Ingredients

    4 FL OZ / 118 ML 1

    2

    1

    2

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82075-410-101 in 1 CARTON07/02/2021
    1118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:82075-410-951 in 1 CARTON11/19/2021
    288 g in 1 TUBE; 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(82075-410)
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