SMITH-AMISH ARTHRITIS CREAM

Drug Facts

Active ingredient

Menthol 1.5%

Purpose

Topical Analgesic

Uses:

Temporarily relief of minor aches and pains of muscles and joints

Warnings:

For external use only
Avoid contact with eyes
If condition worsens, or if symptoms persist for more than 7 days or no improvemeny within a few days, discontinue use of the product and consult a doctor

Do not apply

to wounds or damaged skin
Do not bandage tightly

If pregnant or breast-feeding,

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.

Directions:

Adults and children 12 years 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:

Protect from excessive heat.
Store at 20-25°C (68-77° F)

Inactive ingredients

arnica montana flower extract, cetyl alcohol, ethylhexylglycerin, eucalyptus (Eucalyptus Cinerea), glycerin, glyceryl stearate, jojoba (Simmondsia Chinensis) Seed oil, peppermint (Mentha Piperita) oil, phenoxyethanol, rosemary (Rosemarinus Officinalis), Sodium citrate, stearic acid, sweet almond (Prunus Amygdalus Dulcis) Oil, tea tree (Melaleuca Alternifolia) leaf oil, tocopherol (Vitamin E), water.

Questions?

Call (866) 419-3567 / 8:00 Am-5:00 PM ET-M-F

Package Labeling:

Label

SMITH-AMISH ARTHRITIS
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72609-280
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS CINEREA WHOLE (UNII: 52B2WHC1AK)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
JOJOBA OIL (UNII: 724GKU717M)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY (UNII: IJ67X351P9)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72609-280-04	128 g in 1 JAR; Type 0: Not a Combination Product	10/01/2018	09/28/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/01/2018	09/28/2023

Labeler - Smith-Amish, LLC (081504527)

Revised: 10/2023

Document Id: 074b8112-4200-86a5-e063-6394a90a97c6

Set id: 820fa03c-f85f-414a-a5ba-31758d63af57

Version: 3

Effective Time: 20231009

Smith-Amish, LLC