Label: FRANKINCENSE AND MYRRH INTENSIVE FOOT THERAPY- menthol lotion

  • NDC Code(s): 42346-520-85
  • Packager: Wise Consumer Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2024

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  • Active ingredient

    Menthol 1.3%

  • Purpose

    Menthol 1.3%................Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains.

  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • over large areas of the body

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • irritation occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: consult a doctor.

  • Other information

    • store in a cool, dry place
    • tamper resistant: do not use if seal under tube cap is broken or missing
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Lanolin, Cetearyl Alcohol, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearyl, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 60, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol, Xanthan Gum, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Medica Limonum (Lemon) Peel Oil

  • Questions or comments?

    1-877-917-9674 Mon-Fri, 9 a.m. - 5 p.m. EST

    www.frankincensemyrrh.com

  • PRINCIPAL DISPLAY PANEL

    Frankincense & Myrrh

    Intensive

    Foot

    Therapy

    Lotion

    Safe for Diabetics

    Fast

    Pain Relief

    Hydrating Repair

    Menthol 1.3%

    Temporary

    Topical Analgesic

    Net Wt. 3 oz (85g)

    2

    1

  • INGREDIENTS AND APPEARANCE
    FRANKINCENSE AND MYRRH INTENSIVE FOOT THERAPY 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42346-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRRH OIL (UNII: H74221J5J4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42346-520-851 in 1 CARTON10/09/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/09/2024
    Labeler - Wise Consumer Products (006459643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Labs, Inc.117109069manufacture(42346-520)
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