ZEN HEMP Balm

Manufacturer
Zen Enterprises LLC | CLARION COSMETICS
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:59

Label at a glance#

ProductZEN HEMP Balm
Active ingredientEUCALYPTUS OIL, CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

Temporarily relieves minor aches & pains releated to arthritis, headaches, backaches, joints and muscle pain, cramps and spasms, sprains and other injuries

Dosage and administration

Use only as directed. Apply generously to affected area 3 to 4 times daily. Children under 12, consult a doctor before use.

Storage and handling

Store in a cool, dry place between 20º to 25 ºC (68º-77ºF)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 11%

Eucalyptus Oil 10%

Menthol 8%

Wintergreen Oil (Methyl salicylate) 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Anti-Inflammatory

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches & pains releated to arthritis, headaches, backaches, joints and muscle pain, cramps and spasms, sprains and other injuries

Cautions

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product discontinue use if excessive irritation of the skin develops. Avoid contact with eyes and mucous membranes. Do not bandage. Do not use with a heating pad.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

  • symptoms cear up and occur again within a few days or
  • excessive skin irritation occurs.

Keep out of reach of children to avoid accidental ingestion.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical attention or consult a physician immediately.

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place between 20º to 25 ºC (68º-77ºF)

Directions

DOSAGE & ADMINISTRATION SECTION

Use only as directed. Apply generously to affected area 3 to 4 times daily. Children under 12, consult a doctor before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hemp Oil

Clove Oil

Nutmeg Oil

Cassia Oil

Paraffin Wax

Cinnamon Oil

Pwppermint Oil

White Petroleum Jelly

Borneol Oil Light Liquid Paraffin

Citronella Oil

Beeswax

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73048-005-012026-01-29C16284748780-149896155-a0a3-586f-e063-e6dba90add90ZEN HEMP Balm
73048-005-022026-01-29C16284748780-149896155-a0a3-586f-e063-e6dba90add90ZEN HEMP Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73048-005-01ZEN HEMP Balm20 g in 1 JAROINTMENT201
73048-005-02ZEN HEMP Balm5 g in 1 JAROINTMENT51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73048-005ZEN HEMP BALM (CAMPHOR, EUCALYPTUS OIL,MENTHOL,WINTERGREEN OIL) OINTMENT [ZEN ENTERPRISES LLC]12 package rows20240829_20b8f44d-e837-3c61-e063-6394a90a905e.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73048-00573048-005-01, 73048-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
20b8dc4d-c5e9-db3b-e063-6394a90a29c120b8f44d-e837-3c61-e063-6394a90a905e2024-08-28WarningsExact identifier
spl id: 20b8dc4d-c5e9-db3b-e063-6394a90a29c1
spl set id: 20b8f44d-e837-3c61-e063-6394a90a905e

Reported adverse events (FAERS/openFDA)#

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