SPAI-SONS  ALKALINE DRY-DANDRUFF- pyrithione zinc shampoo 
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.

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SPAI-SONS SHAMPOO ALCALINO ANTI CASPA SECA / ALKALINE SHAMPOO DRY-DANDRUFF

This formula includes Zinc Pyrithione used to eliminate the agent causing dry dandruff and scalp drying.

USE: Hair washing and scalp affected by exfoliation, scales and dry dandruff

This product must be keep out reach of children.

This product is for topical appplication. Wash the hair with the shampoo in the shower.

If this product is contact with eyes rinse immediately with water and consult your doctor

To wash daily during 8 or 10 weeks, soon interdaily use until the remission of the problem. This product is for topical application

This composition moisturizes and lubricate capillary dermis

IMAGE OF THE LABEL  IMAGE OF THE LABEL

SPAI-SONS   ALKALINE DRY-DANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PONCEAU 4R (UNII: Z525CBK9PG)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-017-01210 mL in 1 BOTTLE
2NDC:66854-017-02250 mL in 1 BOTTLE
3NDC:66854-017-03400 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 6/2012
Document Id: 0e71594b-a004-44cb-a8ae-f76ee1b1db4b
Set id: d47c1035-a4b1-4732-86ee-e7d6670a94e3
Version: 1
Effective Time: 20120605
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS