ASSURED MEDICATED BODY 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.

----------

Assured Medicated Body Powder Triple Relief Formula

Active Ingredient

Menthol 0.15%

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, zinc oxide, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate.

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 42669-206-01

ASSURED MEDICATED BODY POWDER

TRIPLE RELIEF FORMULA

Absorbs Moisture
Relieves Itching
Cools Skin

Net wt 10oz (283 g)

Label

ASSURED MEDICATED BODY POWDER
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42669-206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42669-206-01	283 g in 1 BOTTLE; Type 0: Not a Combination Product	11/29/2017	08/01/2023

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

Labeler - Davion, Inc (174542928)

Registrant - Davion, Inc (174542928)

Name	Address	ID/FEI	Business Operations
Establishment
Davion Inc		079536689	manufacture(42669-206)

Revised: 8/2023

Document Id: 01e24f90-a17d-edbf-e063-6294a90a53e4

Set id: c8dad6e4-748f-41c1-98d6-1afa836967ce

Version: 3

Effective Time: 20230801

Davion, Inc