ANTI-DANDRUFF - pyrithione zinc shampoo 
GREENBRIER INTERNATIONAL

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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Drug Facts


Active Ingredient                                          Purpose

Zinc Pyrithione       0.05%                            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

image of shampoo
ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
glycol stearate (UNII: 0324G66D0E)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ammonium chloride (UNII: 01Q9PC255D)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
methylisothiazolinone (UNII: 229D0E1QFA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1130-1396.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/06/2011
Labeler - GREENBRIER INTERNATIONAL (610322518)
Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture

Revised: 12/2011
Document Id: b4f420a8-9123-4fba-8440-caa501ad370d
Set id: ff12e52b-e575-44f5-aeb1-c8e64c115759
Version: 1
Effective Time: 20111206
 
GREENBRIER INTERNATIONAL