ProHEMP Soothing Menthol Rub 4%

Manufacturer
NATURE'S FUSIONS, LLC
Effective date
2022-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:52

Label at a glance#

ProductProHEMP Soothing Menthol Rub 4%
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

temporarily relieves minor aches and pains of muscles and joints due to • arthritis • simple backache • strains • tendonitis • bursitis • sprains • bruises • cramps

OTC - ACTIVE INGREDIENT SECTION

Menthol 4% - External Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.

INACTIVE INGREDIENT SECTION

aloe vera, beta caryophyllene, cellulose, hemp extract, hyaluronic acid, natural fragrances (essential oils, terpenes), organic fractionated coconut oil, potassium citrate, potassium sorbate, purified water, quillaja saponaria extract

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.

WARNINGS SECTION

For external use only

When using this product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or to damaged or very sensitive skin • do not bandage tightly or use with a heating pad • Stop use and ask a doctor if • excessive redness or irritation is present • condition worsens • pain persists for more than 7 days • symptoms clear up and occur again within a few days • If pregnant or breastfeeding, 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 oz tube display panel2 oz tube display panel

4 oz jar display panel 4 oz tub display panel4 oz tub display panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73769-100-042024-01-30C16284748780-11030e365-6807-111a-e063-dadaa90a10e2ProHEMP Pain Relief Soothing Menthol Rub 4%
73769-100-602024-01-30C16284748780-11030e365-6807-111a-e063-dadaa90a10e2ProHEMP Pain Relief Soothing Menthol Rub 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73769-100-04ProHEMP Soothing Menthol Rub 4%113 mL in 1 JARCREAM1132
73769-100-60ProHEMP Soothing Menthol Rub 4%60 mL in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73769-100PROHEMP SOOTHING MENTHOL RUB 4% (MENTHOL) CREAM [NATURE'S FUSIONS, LLC]2Legacy NDC, 2 package rows20220201_d683440d-d818-5818-e053-2995a90a208d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73769-10073769-100-60, 73769-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
d6eb46b9-1df9-5990-e053-2995a90ad5afd683440d-d818-5818-e053-2995a90a208d2022-01-31WarningsExact identifier
spl id: d6eb46b9-1df9-5990-e053-2995a90ad5af
spl set id: d683440d-d818-5818-e053-2995a90a208d

Reported adverse events (FAERS/openFDA)#

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