MEDICATED- menthol, zinc oxide powder 
Vi-Jon

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

Menthol 0.15%

Zinc oxide 1.0%

Purpose

External analgesic

Skin protectant

Uses

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

dries the oozing and weeping of:

Warnings

For external use only

When using this product

avoid contact with the 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 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

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

disclaimer

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

Made in the USA with US and foreign components

Adverse Reactions

Vi-Jon

One Swan Drive

Smyrna, TN 37167

Principal Display Panel

NDC 0869-0551-38

SWAN

medicated

Body Powder

skin protectant/topical analgesic

triple action

Compare to 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 DRUGItem Code (Source)NDC:0869-0551
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0551-38283 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/12/2003
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
M+K Packaging047022405manufacture(0869-0551)

Revised: 5/2013
Document Id: 20f4595b-1c25-4945-9953-6b5c3381557f
Set id: 380ffeae-f613-46f5-8b51-dff66ad832a6
Version: 1
Effective Time: 20130529
 
Vi-Jon