Label: FOOT- menthol cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 13, 2024

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  • Drug Facts Active Ingredient

    Menthol 1.25%

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches and pains

  • Warnings

    • For external use only
    • Avoid contact with eyes

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

    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 over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

  • Other information

    Protect from excessive heat

    Store at 20-25 oC (68-77F)

  • Inactive Ingredients

    Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

  • Questions?

    Call (866) 419-3567

    Monday through Friday 8:00am - 2:00pm ET

  • SPL UNCLASSIFIED SECTION

    Tamper evident: Do not use if safety seal under cap is broken or missing.

    Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

  • Label

    Smith Amish Arthritis Cream (72609-702-02)

    Provides Penetrating Relief

    • Arthritic pain
    • Muscle Pain
    • Joint Pain
    • Back Pain

    Fresh scent from Arnica & Eucalyptus

    All natural and non-greasy

    Net wt. 2oz (59g)

    label

  • INGREDIENTS AND APPEARANCE
    FOOT 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72609-703
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72609-703-021 in 1 BOX08/28/2024
    159 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/28/2024
    Labeler - Smith Amish, LLC (081504527)
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