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NDC 72609-0200-40 Smith Amish Foot 1.25 g/100g Details

Smith Amish Foot 1.25 g/100g

Smith Amish Foot is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Smith Amish, LLC. The primary component is MENTHOL.

Product Information

NDC	72609-0200
Product ID	72609-200_dbd84015-6a19-4a61-e053-2a95a90ac70d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Smith Amish Foot
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1.25
Active Ingredient Units	g/100g
Substance Name	MENTHOL
Labeler Name	Smith Amish, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72609-0200-40 (72609020040)

Pricing Information	N/A
NDC Package Code	72609-200-40
Billing NDC	72609020040
Package	128 g in 1 JAR (72609-200-40)
Marketing Start Date	2022-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbd84015-6a18-4a61-e053-2a95a90ac70d Details

Drug Facts

Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SMITH AMISH FOOT

menthol cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Smith Amish, LLC (081504527)

Revised: 4/2022

Document Id: dbd84015-6a19-4a61-e053-2a95a90ac70d

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

Version: 1

Effective Time: 20220404