FOOT by Smith Amish, LLC FOOT- menthol cream

FOOT by

Drug Labeling and Warnings

FOOT 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 1.25%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains

Warnings

• For external use only
• Avoid contact with eyes

• If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor.

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 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Other information

Protect from excessive heat

Store at 20-25 oC (68-77F)

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 amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

SPL UNCLASSIFIED SECTION

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Label

Smith Amish Arthritis Cream (72609-702-02)

Provides Penetrating Relief

• Arthritic pain
• Muscle Pain
• Joint Pain
• Back Pain

Fresh scent from Arnica & Eucalyptus

All natural and non-greasy

Net wt. 2oz (59g)

INGREDIENTS AND APPEARANCE

FOOT 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72609-703
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)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72609-703-02	1 in 1 BOX	08/28/2024
1		59 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/28/2024

Labeler - Smith Amish, LLC (081504527)