FDA.reportPublic FDA data

Amish Origins Pain Relieving Ointment, Menthol 8%

Manufacturer
Amish Origins Management, LLC
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:14

Label at a glance#

ProductAmish Origins Pain Relieving Menthol 8%
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pain of muscles and joints associated with arthritis

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain of muscles and joints associated with arthritis

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical helpor contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Camphor Oil, Eucalyptus Oil, Methyl Salicylate, Pine Needle Oil, Snow White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-530-7643

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03Label03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282808menthol 8 % Topical OintmentPSN1
282808menthol 0.08 MG/MG Topical OintmentSCD1
282808menthol 8 % Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62212-002-01Amish Origins Pain Relieving Menthol 8%99 g in 1 JAROINTMENT991

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62212-002AMISH ORIGINS PAIN RELIEVING MENTHOL 8% (MENTHOL) OINTMENT [AMISH ORIGINS MANAGEMENT, LLC]1Current NDC, 1 package rows20240301_b120404f-5a07-4182-bb50-d943418622da.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62212-00262212-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR OIL75IZZ8Y727IACT
EUCALYPTUS OIL2R04ONI662IACT
METHYL SALICYLATELAV5U5022YIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
MENTHOLL7T10EIP3AACTIB

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
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
ndc (package): 62212-002-01
ndc (product): 62212-002
ndc11 (package): 62212000201
spl id: 128763e6-85ee-c56c-e063-6294a90a621f
spl set id: b120404f-5a07-4182-bb50-d943418622da

Reported adverse events (FAERS/openFDA)#

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