Label: ZAXS ACHES AND PAIN- capsicum, methyl salicylate, menthol cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2024

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  • ACTIVE INGREDIENT

    Capsicum 0.13%

    Methyl Salicylate 10.5%

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, Arthritis, Strains, Bruises, Sprains. Penetrating pain relief.

  • DOSAGE & ADMINISTRATION

    For use by Adults and Children over 12 years of age: Apply a thin layer to affected area, not more than 4 times a day. Rub and massage into skin until solution vanishes. Always wash hands after applying. Store in airtight, light resistant container at room temperature.

  • WARNINGS

    • For external use only.

    •Allergy alert: If allergic to aspirin or salicylates, consult a physician before use.

    •When using this product, use only as directed. Make sure you understand directions and warnings on label before use.

    °Rare case of burns have been reported with products of this type.

    °Do not apply with external heat (such as electric heating pad) or bandage tightly.

    °Do not apply to wounds or damaged skin, or irritated skin.

    °If you are allergic to any ingredient in this product, do not use. Avoid contact with eyes and mucous membranes.

    •If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    •Stop use if: Redness is present, irritation develops, you experience pain, swelling or blistering where product is applied.

    •Consult a physician if you are breastfeeding or pregnant before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult a Poison Control Centre immediately.

  • INACTIVE INGREDIENT

    Aqua, Butyrospermum Parkii (Shea Butter) Extraxt, Caprylic/capric triglyceride, Caprylyl Glycol, Camphor, Carbomer copolymer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Leaf Oil, Glycerin, Mentha piperita (Peppermint) oil, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Sorbic acid, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Tube Label Tube Label

  • INGREDIENTS AND APPEARANCE
    ZAXS ACHES AND PAIN 
    capsicum, methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82186-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM1.3 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82186-162-01120 g in 1 TUBE; Type 0: Not a Combination Product11/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/22/2021
    Labeler - Zax Healthcare Inc. (247378271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(82186-162)