PREMIER VALUE MEDICATED BODY POWDER- menthol and zinc oxide powder

Premier Value Medicated Body Powder by

Drug Labeling and Warnings

Premier Value 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 Ingredients

Menthol 0.15%
Zinc Oxide 1.0%

Purpose

Anti-itch
Skin Protectant

Uses

temporarily relieves pain and itch associated with:

• minor cuts
• sunburn
• insect bites
• rashes
• scrapes
• minor burns
• minor skin irritations
• prickly heat

Dries the oozing of:

• poison ivy
• poison oak
• poison sumac

Warning

For external use only.

• Avoid contact with eyes

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, 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, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate.

Product Label

INGREDIENTS AND APPEARANCE

PREMIER VALUE MEDICATED BODY POWDER 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
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: 42669-203-01	283 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/29/2009

Labeler - Davion, Inc. (174542928)