SPAI-SONS ACID ANTI-DANDRUFF

Dosage form: shampoo
Ingredients: SULFUR 0.4mL in 100mL
Labeler: SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS
NDC Code: 66854-021

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 SHAMPOO ACIDO ANTI-CASPA / ACID SHAMPOO ANTI-DANDRUFF

This formula includes Biosulfur fluid, that is highest effectiveness for the scalp.

This fromula includes the active ingredient containing the highest effectiveness for the scalp called greasy dandruff

This product must be keep out reach of children

This product is for topical application. 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. The product is for topical application.

Its components make it tolerable for daily use or washing the scalp affected

IMAGE OF THE LABEL

SPAI-SONS  ACID ANTI-DANDRUFF
sulfur shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR0.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
GLYCOL DISTEARATE 
SODIUM LAURETH SULFATE 
SODIUM LAURETH SULFATE 
COCO MONOETHANOLAMIDE 
LAURETH-10 
DIPYRITHIONE 
PANTHENOL 
POLYSORBATE 80  
TROLAMINE 
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
PROPYLPARABEN 
SODIUM CHLORIDE 
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:66854-021-01210 mL in 1 BOTTLE
2NDC:66854-021-02250 mL in 1 BOTTLE
3NDC:66854-021-03250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2012
Labeler - SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIOperations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 06/2012
 
SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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