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NDC 72609-0280-04 SMITH-AMISH ARTHRITIS 15 mg/g Details

SMITH-AMISH ARTHRITIS 15 mg/g

SMITH-AMISH ARTHRITIS 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	72609-0280
Product ID	72609-280_7859ed43-29ef-14d8-e053-2991aa0a7e32
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 ARTHRITIS
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	15
Active Ingredient Units	mg/g
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	2022-12-31

Package

Package Images

NDC 72609-0280-04 (72609028004)

Pricing Information	N/A
NDC Package Code	72609-280-04
Billing NDC	72609028004
Package	128 g in 1 JAR (72609-280-04)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 820fa03c-f85f-414a-a5ba-31758d63af57 Details

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

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

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

Labeler - Smith-Amish, LLC (081504527)

Revised: 10/2018

Document Id: 7859ed43-29ef-14d8-e053-2991aa0a7e32

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

Version: 2

Effective Time: 20181016