Label: CU PAIN AWAY PAIN RELIEF- menthol cream

  • NDC Code(s): 71304-001-00
  • Packager: Canadian Unique Health Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 1.25%

    Purpose

    Counterirritant

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only. Avoid contact with the eyes and mucous membranes.

    When using this product

    • use only as directed
    • do not apply to wounds or damaged skin
    • 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
    • irritation of the skin develops                                                                                                                                                                           If pregnant or breast-feeding, 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

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: Consult a doctor
  • Other information

    • Store in a cool dry place
    • Protect from heat and light
  • Inactive ingredients

    aloe (Aloe barbadensis) leaf juice, avocado (Persea gratissima) oil, caprylyl glycol, cetearyl alcohol, coco-caprylate, coconut (Cocos nucifera) oil, cupric oxide, disodium EDTA, isoamyl cocoate, isopropyl palmitate, jojoba (Simmondsia chinensis) seed oil, lavender (Lavandula angustifolia) oil, lemon (Citrus limon) oil, phenoxyethanol, polysorbate 60, silk amino acids, sodium lactate, stearic acid, tea tree (Melaleuca alternifolia) leaf oil, tocopherol

  • Questions or comments?

    Call 1-844-893-3085 Monday through Friday, 9-5pm EST or visit www.canadianunique.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CU PAIN AWAY PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71304-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CUPRIC OXIDE (UNII: V1XJQ704R4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ISOAMYL COCOATE (UNII: 14OG46E98E)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON OIL (UNII: I9GRO824LL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71304-001-001 in 1 BOX03/08/2017
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/08/2017
    Labeler - Canadian Unique Health Ltd. (203413273)
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