Smith Amish Foot Cream (NDC: 72609-200-40)

Smith Amish Foot by

Drug Labeling and Warnings

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

Drug Details [pdf]

SMITH AMISH FOOT- menthol cream 
Smith Amish, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Smith Amish Foot Cream (NDC: 72609-200-40)

Drug Facts

Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain

For external use only

Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or no imporivement 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 degrees C (68-77 Farenheit)

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, glycerin, glyceryl stearate, jojoba (Buxus Chinensis) oil, peppermint (mentha piperita oil), phenoxyethanol, sodium citrate, stearic acid, sweet almond (prunus amygdalus dulcis) oil, tea tree (Melaluca Alternifolia) oil, tocopherol (vitamin E), water

Questions?

Call (866) 419-3567)

Monday through friday 8:00am - 4:00pm ET

Drug Product Label

Smith Amish Foot Cream

Deep Soothing Relief

for intense foot and leg discomfort

(NDC: 72609-200-40)

SMITH AMISH FOOT 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72609-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
JOJOBA OIL (UNII: 724GKU717M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72609-200-40	128 g in 1 JAR; Type 0: Not a Combination Product	04/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2022	03/23/2023

Labeler - Smith Amish, LLC (081504527)

Revised: 3/2023

Document Id: f8349920-f292-48d8-e053-6294a90af073

34390-5

Set id: dbd84015-6a18-4a61-e053-2a95a90ac70d

Version: 2

Effective Time: 20230331