ASSURED MEDICATED BODY POWDER- menthol powder

Assured Medicated Body Powder by

Drug Labeling and Warnings

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

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ASSURED MEDICATED BODY POWDER 
menthol powder

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Davion, Inc (174542928)

Registrant - Davion, Inc (174542928)

Establishment
Name	Address	ID/FEI	Business Operations
Davion, Inc		174542928	manufacture(42669-206)