MEDICATED- menthol, zinc oxide powder

Medicated by

Drug Labeling and Warnings

Medicated by is a Otc medication manufactured, distributed, or labeled by DZB Brands, LLC, Vi-Jon, M+K Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredients

Menthol 0.15%

Zinc oxide 1.0%

Purpose

Purpose

External analgesic

Skin protectant

Uses

Uses for the temporary relief of pain and itching due to:

• minor cuts
• sunburn
• insect bites
• poison ivy
• poison oak
• poison sumac
• scrapes
• minor burns
• minor skin irritations

dries the oozing and weeping of:

• poison ivy
• poison oak
• poison sumac

Warnings

Warnings

For external use only

When using this product

When using this product avoid contact with the eyes

Stop use

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - do not use, consult a doctor

• for best results dry skin thoroughly before applying

Inactive ingredients

Inactive ingredients talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Disclaimer

This product is not manufractured or distributed by Chattem, Inc., owner of the registered tradmark Gold Bond

This product is sold by weight, not by volume. Some settling may occur during handling and shipping

Advese reactions

Distributed by: DZA Brands, LLC

2110 Excutive Drive

Salisbury, NC 28147

For Product questions or concerns

contact us at 1-866-322-2439. Please include UPC number and code from package

Principal Display Panel

Healthy

Accents

medicated

body powder

external analgesic

cooling - absorbing- itch relieving

Compare to the active ingredients of Gold Bond Medicated Body Powder

NET WT 10 OZ (283 g)

INGREDIENTS AND APPEARANCE

MEDICATED 
menthol, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ACACIA (UNII: 5C5403N26O)
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: 55316-551-38	283 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2011

Labeler - DZB Brands, LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
M+K Packaging		047022405	manufacture(55316-551)