MEDICATED- menthol and zinc oxide powder 
DZB Brands, LLC

Disclaimer: 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.

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Drug Facts

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:

dries the oozing and weeping of:

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

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)

image description

MEDICATED 
menthol, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-551
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.5 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC 
ACACIA 
EUCALYPTOL 
METHYL SALICYLATE 
SALICYLIC ACID 
THYMOL 
ZINC STEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-551-38283 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2011
Labeler - DZB Brands, LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
M+K Packaging047022405manufacture(55316-551)

Revised: 1/2013
Document Id: 8b1fea8c-b300-4da7-8427-2e5b7a07d358
Set id: 915f8963-feda-4b48-b2ca-013f01f49574
Version: 1
Effective Time: 20130121
 
DZB Brands, LLC