HEALTH SMART MEDICATED BODY- menthol and zinc oxide powder 
International Wholesale Inc dba Home Smart Products

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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Health Smart Medicated Body Powder

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%

Purpose

External Analgesic

Skin Protectant

Uses

For the temporary relief of pains and itch associated with:

Warnings

For external use only.

When using this product avoid contact with eyes.

Consult a doctor and discontinue use if

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

adults and children 2 years and over

Inactive Ingredients

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
ACACIA (UNII: 5C5403N26O)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-020-22283 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/27/2014
Labeler - International Wholesale Inc dba Home Smart Products (161872676)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-020)

Revised: 8/2020
Document Id: ac9d655f-6efa-c4a6-e053-2a95a90a14b6
Set id: 3bf911c7-02f2-4744-ad87-452b24422ea9
Version: 2
Effective Time: 20200811
 
International Wholesale Inc dba Home Smart Products