Assured Medicated Foot Powder Triple Relief Formula

Assured Medicated Foot Powder by

Drug Labeling and Warnings

Assured Medicated Foot Powder by is a Otc medication manufactured, distributed, or labeled by Davion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASSURED 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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Assured Medicated Foot Powder Triple Relief Formula

Active Ingredient

Menthol 1.0%

Purpose

External Analgesic

Uses

Temporary relief of pain and itch associate with:

• minor cuts
• sunburn
• insect bites
• scrapes
• minor burns
• minor skin irritations

Warning

• For external use only
• Avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within few 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 upto 3 or 4 times daily
• children under 2 years - ask a doctor
• For best results, dry skin throughly before applying

Inactive ingredients

Talc, Sodium Bicarbonate, Benzethonium Chloride, Eucalyptus Oil, Peppermint Oil

Warning

This product contains talcum powder and is intended for external use only. Frequent application of talcum powder in the female genital area may increase the risk of ovarian cancer

PRINCIPAL DISPLAY PANEL

NDC: 42669-207-01

ASSURED MEDICATED FOOT POWDER

TRIPLE RELIEF FORMULA

• Absorbs Moisture
• Relieves Itching
• Cools Skin

Net wt 8oz (227 g)

ASSURED MEDICATED FOOT POWDER 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-207
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)
EUCALYPTUS OIL (UNII: 2R04ONI662)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42669-207-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	11/29/2017	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/29/2017	08/01/2023

Labeler - Davion, Inc (174542928)

Registrant - Davion, Inc (174542928)

Establishment
Name	Address	ID/FEI	Business Operations
Davion, Inc		079536689	manufacture(42669-207)

Revised: 8/2023

Document Id: 01e2646a-b7f8-29ee-e063-6294a90a103c

34390-5

Set id: 545b3070-6929-46a6-9d9f-934a98008b04

Version: 5

Effective Time: 20230801