PREMIER VALUE MEDICATED FOOT POWDER- menthol powder 
Davion, 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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Premier Value Medicated Foot Powder

Active Ingredients

Menthol 1.0%

Purpose

Anti-itch

Uses

For the temporarily relief of the pain and itch associated with:

  • minor skin irritations on the foot
  • absorbs excess moisture
  • helps control foot odor and odor-causing bacteria
  • cools and soothes irritated skin

Warning

For external use only.

  • Avoid contact with eyes

Stop use 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.
  • children under 2 years ask a doctor.
  • For best results, dry skin thoroughly before applying.

Inactive Ingredients

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

Product Label

image Product Label

PREMIER VALUE MEDICATED FOOT POWDER 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-204
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)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42669-204-01283 g in 1 CONTAINER; Type 0: Not a Combination Product12/05/202208/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/05/201408/01/2023
Labeler - Davion, Inc. (174542928)
Registrant - Davion, Inc. (174542928)
Establishment
NameAddressID/FEIBusiness Operations
Davion, Inc079536689manufacture(42669-204)

Revised: 8/2023
Document Id: 01e23a72-0f8b-0a5c-e063-6294a90aa62f
Set id: 91e6a01f-a9a4-4bcb-82a3-7dd0e2f31770
Version: 3
Effective Time: 20230801
 
Davion, Inc.