Label: PAIN RELIEF CREAM- menthol cream

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

Drug Label Information

Updated December 16, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients  Menthol 1.25%

  • 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, Cananga Odorata (Ylang
    Ylang) Flower Oil, Caprylic/Capric Trigl-
    yceride, 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

  • Principal Display Package Labeling

    SanaMax PLUS

    BALANCED FORMULA

    SanaMax PLUS

    PAIN RELIEF CREAM

    Temporary relief from backache,

    minor arthritis, muscle and joint pain.

    Quick Absorbing         Paraben Free

    Non Staining               Non-Greasy

    Non-Burning               Fast Relief

    Relaxing Scent            Calming Effect

           DOCTOR RECOMMENDED

    WITH 12 ESSENTIAL OILS

    NET WT 1 OZ (28g)

    SanaMax PLUS

    PAIN RELIEF CREAM

    SanaMax Plus is trusted
    by medical doctors,
    pharmacists, physical
    therapists, chiropractors,
    massage therapists,
    podiatrists, and athletic
    trainers. It applies easily
    and penetrates quickly for
    fast temporary relief from
    sore muscles, backaches,
    sore joints, and arthritis.

    SanaMax Plus is a balanced formula that contains 12
    essential oils. It is quick absorbing but is not greasy, does not
    stain, has a relaxing scent, a calming effect, and does not
    burn.

    SanaMax Plus is not tested on animals, is made in the USA
    with USP grade ingredients, is free of parabens, and
    propylene glycol.

    Distributed by:                        Questions or Comments
    SanaMax Plus LLC                       sanamaxplus.com
    McAllen, TX 78501

                          NDC 72425-201-02

    8  60473 00240  2

    PE 2020/013

       VER 01

    BOX

    SanaMax Box 201

    SanaMax Box 201

    TUBE

    SanaMax Tube 201

    SanaMax Tube 201

    res

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72425-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    ORANGE OIL (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 MONOSTEARATE (UNII: 230OU9XXE4)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72425-201-021 in 1 BOX12/02/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/02/2019
    Labeler - SanaMax Plus LLC (081260808)
    Registrant - Identipak, Inc. (942862350)
    Establishment
    NameAddressID/FEIBusiness Operations
    Identipak, Inc.942862350manufacture(72425-201)