MedPath

ARTHRITIS

Smith Amish Arthritis Cream (2oz) - 72609-702-02

Approved
Approval ID

20c36972-b695-1241-e063-6394a90adf63

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 11, 2025

Manufacturers
FDA

Smith Amish, LLC

DUNS: 081504527

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MENTHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72609-702
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2025
FDA Product Classification

INGREDIENTS (16)

ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
MENTHOLActive
Quantity: 1.25 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
ARNICA MONTANA WHOLEInactive
Code: O80TY208ZW
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROSEMARY OILInactive
Code: 8LGU7VM393
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

Label

Smith Amish Arthritis Cream (72609-702-02)

Provides Penetrating Relief

  • Arthritic pain
  • Muscle Pain
  • Joint Pain
  • Back Pain

Fresh scent from Arnica & Eucalyptus

All natural and non-greasy

Net wt. 2oz (59g)

label

Smith Amish Arthritis Cream (72609-702-02)

4oz cream label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/28/2024

Uses

Temporarily relieves minor aches and pains of muscles and joints.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/28/2024

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/28/2024

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/28/2024

Drug Facts

Active Ingredient

Menthol 1.25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/28/2024

Purpose

Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/28/2024

Warnings

  • For external use only

  • Avoid contact with eyes

  • If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/28/2024

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/28/2024

Directions

Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/28/2024

Other information

Protect from excessive heat

Store at 20-25 oC (68-77F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/28/2024

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.