HEALTH SMART MEDICATED FOOT- menthol powder

Health Smart Medicated Foot by

Drug Labeling and Warnings

Health Smart Medicated Foot by is a Otc medication manufactured, distributed, or labeled by International Wholesale Inc dba Home Smart Products, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol     1.0%

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of pains and itch associated with minor skin irritation on the foot:

• Absorbs Excess Moisture
• Helps Control Foot Odor and Odor-Causing Bacteria
• Cools and Soothes Irritated Skin

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product avoid contact with eyes.

ASK DOCTOR

Consult a doctor and discontinue use if

• condition worsens
• symptoms do not get better within 1 week.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• adults and children 2 years and over: apply to the affected area not more than 3 or 4 times daily.
• children under 2 years of age: consult a physician.
• for best results, wash and dry feet, sprinkle powder liberally over feet, between toes, on bottoms of feet and in shoes.

INACTIVE INGREDIENT

Inactive Ingredients

talc, sodium bicarbonate, acacia, benzethonium chloride, eucalyptus oil and peppermint oil.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED FOOT POWDER

NET WT. 10 OZ. (283g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SMART MEDICATED FOOT 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ACACIA (UNII: 5C5403N26O)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-021-22	283 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/27/2014

Labeler - International Wholesale Inc dba Home Smart Products (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-021)