PERSONAL CARE - medicated foot powder powder 
Personal Care Products, Inc.

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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Personal Care Medicated Foot Powder

Active ingredients                              Purpose
Menthol 1 percent               External analgesic

Uses     for the temporary relief of the pain 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
For external use only
When using this product avoid contact with eyes.

Stop using and ask a doctor if
- condition worsens  - symptoms do not get better within 7 days

Keep out of reach of children. In case of accidental ingestion, get medical help or
contact a Poison Control Center right away.

Directions
- adults and children 2 years and older, apply freely up to 3 or 4 times daily
- under 2 years: ask a doctor before using
- wash and dry feet, sprinkle powder liberally over feet, between toes, on bottoms of feet, and in shoes

Inactive ingredients
talc, sodium bicarbonate, acacia, benzethonium chloride, eucalyptus oil, peppermint oil

Personal Care Medicated Foot Powder

PERSONAL CARE 
medicated foot powder powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol20 mg  in 2 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:29500-9091-1283 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2009
Labeler - Personal Care Products, Inc. (603124298)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture

Revised: 9/2009
Document Id: 81b6c114-1bac-49de-a7db-cf436fec662a
Set id: 764469b9-8965-4714-a58e-fd81d3938515
Version: 2
Effective Time: 20090907
 
Personal Care Products, Inc.