FDA.reportPublic FDA data

Frankincense and Myrrh

Manufacturer
Wise Consumer Products Co. | PJ Noyes Co. Inc.
Effective date
2022-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:08

Label at a glance#

ProductFrankincense and Myrrh
Active ingredientHYPERICUM PERFORATUM
Label structure14 sections

Indications and uses

For the temporary relief of minor aches and pains.

Dosage and administration

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.

Storage and handling

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hypericum perforatum 3X HPUS

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

Purpose

OTC - PURPOSE SECTION

Hypericum perforatum 3X HPUS.......Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains.

Warnings

WARNINGS SECTION

For external use only.

Do not use

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes
  • do not bandage tightly

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Manufactured in New Hampshire for:

Wise Consumer Products Co.

PO Box 42400, Cincinnati OH 45242

B.A.E.R

PACKAGE LABEL.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)

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42346-519-85Frankincense and Myrrh1 g in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42346-519FRANKINCENSE AND MYRRH (INTENSIVE FOOT THERAPY LOTION) LOTION [WISE CONSUMER PRODUCTS CO.]3Current NDC, Legacy NDC, 1 package rows20221228_a8eb22f5-d6ea-caed-e053-2995a90a1f7b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42346-51942346-519-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
CINNAMON LEAF OILS92U8SQ71VIACT
XANTHAN GUMTTV12P4NEEIACT
ROSEMARY OIL8LGU7VM393IACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
MYRRH OILH74221J5J4IACT
COCONUT OILQ9L0O73W7LIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
METHYLPARABENA2I8C7HI9TIACT
STEARIC ACID4ELV7Z65APIACT
LANOLIN7EV65EAW6HIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCOA BUTTER512OYT1CRRIACT
PEPPERMINT OILAV092KU4JHIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
NUTMEG OILZ1CLM48948IACT
PROPYLPARABENZ8IX2SC1OHIACT
FRANKINCENSE OIL67ZYA5T02KIACT
LEMON OILI9GRO824LLIACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frankincense and MyrrhINTENSIVE FOOT THERAPY LOTIONWise Consumer Products Co.a8eb22f5-d6ea-caed-e053-2995a90a1f7b2022-12-27WarningsExact identifier
ndc (package): 42346-519-85
ndc (product): 42346-519
ndc11 (package): 42346051985
spl id: f0d4b5b1-47d7-d381-e053-2a95a90a50e9
spl set id: a8eb22f5-d6ea-caed-e053-2995a90a1f7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.