HEALTH SMART MEDICATED FOOT- menthol powder 
International Wholesale Inc dba Home Smart Products

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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Health Smart Medicated Foot Powder

Active Ingredient

Menthol     1.0%

Purpose

External Analgesic

Uses

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

Warnings

For external use only.

When using this product avoid contact with eyes.

Consult a doctor and discontinue use if

Keep out of reach of children

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

Directions

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED FOOT POWDER

NET WT. 10 OZ. (283g)

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED FOOT 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ACACIA (UNII: 5C5403N26O)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-021-22283 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/27/2014
Labeler - International Wholesale Inc dba Home Smart Products (161872676)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-021)

Revised: 8/2020
Document Id: ac9d954b-9cdd-d059-e053-2995a90a2ddc
Set id: 3624b8c6-caa2-4e6c-a851-28afbe38c8c2
Version: 2
Effective Time: 20200811
 
International Wholesale Inc dba Home Smart Products