SPAI-SONS FINE TALCUM- talc powder 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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.

----------

SPAI-SONS TALCO FINO / POWDER FINE TALCUM

The active ingredient are Talc and Zinc Oxide

This product is used to keep cool moist areas of the body as the feet and armpits, and retain moisture from them.

Keep out of reach of children this product

Use the product in the feet after the shower

Do not take this product is only for topical application. If swallowed consult your doctor.

This product is for topical application, apply a moderate amount desired area.

Inactive ingredients not produce irritation or healt effects.

IMAGE OF THE LABEL IMAGE OF THE LABELIMAGE OF THE LABEL

SPAI-SONS  FINE TALCUM
talc powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC81 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
STARCH, CORN (UNII: O8232NY3SJ)  
BORIC ACID (UNII: R57ZHV85D4)  
Product Characteristics
Colorwhite (WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-018-01150 g in 1 BOTTLE
2NDC:66854-018-02250 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/30/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, manufacture, label, pack

Revised: 6/2012
Document Id: 58da040b-6dcb-47d4-8617-b5eae34c1718
Set id: 42fe9319-dcf8-4e94-a45d-d4d1876ed10c
Version: 1
Effective Time: 20120605
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS