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Hair and Scalp anti-dandruff

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1g in 100mL
Labeler: GREENBRIER INTERNATIONAL
NDC Code: 33992-1131

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.

Drug Facts


Active Ingredient                                     Purpose

Zinc Pyrithione       1%                            Anti-dandruff


Help prevent recurrence of flaking and itching associated with dandruff.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.

Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.

For best results, use at least twice a week or as directed by a doctor.

For maximum dandruff control, use every time you shampoo.

For external use only.

Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

apply as needed.

water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5

HAIR AND SCALP ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1131
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
cocamidopropyl betaine 
glycol stearate 
CARBOMER COPOLYMER TYPE A 
ammonium chloride 
methylchloroisothiazolinone 
methylisothiazolinone 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:33992-1131-1400 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/08/2013
Labeler - GREENBRIER INTERNATIONAL (610322518)
Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Establishment
NameAddressID/FEIOperations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture(33992-1131)

Revised: 05/2013
 
GREENBRIER INTERNATIONAL

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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