RxNorm Names

Review RxNorm Normal Forms

MEDICATED (menthol, zinc oxide) powder
[DZB Brands, LLC]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=915f8963-feda-4b48-b2ca-013f01f49574

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredients

Menthol 0.15%

Zinc oxide 1.0%

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

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

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

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)

image description

MEDICATED
menthol, zinc oxide powder

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	1.5 mg in 1 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC
ACACIA
EUCALYPTOL
METHYL SALICYLATE
SALICYLIC ACID
THYMOL
ZINC STEARATE

Packaging
#	Item Code	Package Description
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)

Revised: 01/2013

Document Id: 8b1fea8c-b300-4da7-8427-2e5b7a07d358

Set id: 915f8963-feda-4b48-b2ca-013f01f49574

Version: 1

Effective Time: 20130121

DZB Brands, LLC

Daily Med

Current Medication Information

Options

Additional Resources