TALC-FREE MEDICATED BODY- menthol powder

talc-free medicated body by

Drug Labeling and Warnings

talc-free medicated body 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 associated 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

Remove seal beneath cap before first use. Do not use if seal is broken or missing.

• 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

Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

PRINCIPAL DISPLAY PANEL

NDC: 42669-209-01

Compare to active ingredient in Gold Bond® Medicated Body Powder*

talc-free medicated body powder

triple relief formulahelps absorb moisture

helps soothe skin and relieves itching

NET WT 10oz (283 g)

INGREDIENTS AND APPEARANCE

TALC-FREE MEDICATED BODY 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-209
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
STARCH, CORN (UNII: O8232NY3SJ)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ZINC STEARATE (UNII: H92E6QA4FV)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42669-209-01	283 g in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2018

Labeler - Davion, Inc (174542928)

Registrant - Davion, Inc (174542928)

Establishment
Name	Address	ID/FEI	Business Operations
Davion, Inc		174542928	manufacture(42669-209)