Label: FRANKINCENSE AND MYRRH- intensive foot therapy lotion lotion

  • NDC Code(s): 42346-519-85
  • Packager: Wise Consumer Products Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 27, 2022

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  • Drug Facts

  • Active Ingredients

    Hypericum perforatum 3X HPUS

    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • Purpose

    Hypericum perforatum 3X HPUS.......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

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

  • STOP USE

    Stop use and ask a doctor

    • if condition worsens
    • if irritaion occurs
    • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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.
    • claims based on traditional homeopathic practice; not accepted medical evidence. Not FDA evaluated.
  • Inactive Ingredients

    Water, caprylic/capric triglycerides, emulsifying wax, coccos nucifera (coconut) oil, butyrospermum parkii (shea) butter, lanolin, glycerin, theobroma cacao (cocoa) seed butter, cetyl alcohol, stearic acid, glyceryl stearate, eucyalyptus globulus leaf oil, romarinus officinalis (rosemary) leaf oil. pelargonium graveolens (geranium) flower oil, sodium hydroxide, cinnamomum zeylanicum (cinnamon) leaf oil, xanthan gum, methyl paraben, mentha piperita (peppermint) oil, citrus aurantium bergamia (bergamot) fruit oil, myristica fragrans (nutmeg) kernel oil, propylparaben, menthol, boswellia carterii (frankincense) oil, commiphora myrrha (myrrh) oil, citrus limon (lemon) peel oil.

  • Questions or Comments?

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

    www.frankincensemyrrh.com

  • SPL UNCLASSIFIED SECTION

    Manufactured in New Hampshire for:

    Wise Consumer Products Co.

    PO Box 42400, Cincinnati OH 45242

    B.A.E.R

  • PRINCIPAL DISPLAY PANEL

    Frankincense & Myrrh

    Intensive Foot Therapy Lotion

    Dual Action

    Temporary Pain Relief

    Hydrating Repair

    Pain Relieving

    Topical Lotion

    HOMEOPATHIC

    Net Wt. 3Oz (85g)

    1

  • INGREDIENTS AND APPEARANCE
    FRANKINCENSE AND MYRRH 
    intensive foot therapy lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42346-519
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MYRRH OIL (UNII: H74221J5J4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42346-519-851 g in 1 CARTON; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2020
    Labeler - Wise Consumer Products Co. (006459643)
    Establishment
    NameAddressID/FEIBusiness Operations
    PJ Noyes Co. Inc.018927392manufacture(42346-519)
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