Label: SANAMAX MENTHOL PAIN RELIEF CREAM CBD- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients  Menthol 4%

  • PURPOSE

    Purpose  Topical analgesic

  • INDICATIONS & USAGE

    Uses: temporarily relieves the minor aches and pains of muscles and
    joints associated with:  ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • WARNINGS

    Warnings
    For external use only.

  • DO NOT USE

    Do not use: ■ on wounds, damaged, broken, or irritated skin

    ■ with a heating pad  ■ on a child under 12 years of age with

    arthritis-like conditions.

  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product ■ avoid contact with eyes or mucous membrane

    ■ do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if
    ■ condition worsens or symptoms persist for more than 7 days
    ■ skin irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

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

  • DOSAGE & ADMINISTRATION

    Directions
    ■ use only as directed ■ adults and children 12 years of age and
    older: apply to affected area 3 to 4 times daily
    ■ children under 12 years of age: ask a doctor before use

  • OTHER SAFETY INFORMATION

    Other information:

    ■ Store at 68° to 77°F (20° to 25°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Benzyl Alcohol, Cannabidiol, Cananga Odorata (Ylang Ylang) Flower Oil, Caprylic/
    Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Matricaria)
    Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium
    Dulcis (Orange) Peel Oil, Crambe Abyssinica Seed Oil, Cymbopogon Schoenanthus
    Oil, Ethyl- hexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate,
    Helichrysum Italicum Flower Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin,
    Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, PEG-40
    Hydrogenated Castor Oil, PEG-6, Phenoxyethanol, Pogostemon Cablin (Patchouli)
    Oil, Polyglyceryl-3 Ricinoleate, Salvia Sclarea (Clary Sage) Oil, Sodium Acrylate/
    Sodium Acryloyldimethyl Taurate Copolymer, Water/Aqua

  • Labeling

    SanaMax

    MENTHOL PAIN RELIEF CREAM
    CBD 300mg

    3.4 FL OZ (100mL)

    Distributed by:
    SanaMax Plus, LLC
    McAllen, TX 78501

    Questions or Comments? sanamaxplus.com

    100mL 210-03

    100mL 210-03

    res

  • INGREDIENTS AND APPEARANCE
    SANAMAX MENTHOL PAIN RELIEF CREAM  CBD
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72425-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72425-210-03100 mL in 1 TUBE; Type 0: Not a Combination Product05/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/31/2022
    Labeler - SanaMax Plus LLC (081260808)
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