SMITH-AMISH ARTHRITIS- menthol cream

SMITH-AMISH ARTHRITIS by

Drug Labeling and Warnings

SMITH-AMISH ARTHRITIS by is a Otc medication manufactured, distributed, or labeled by Smith-Amish, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SMITH-AMISH ARTHRITIS 
menthol cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2018

Labeler - Smith-Amish, LLC (081504527)