MODESA 2 IN 1 DANDRUFF GREEN APPLE- pyrithione zinc shampoo 
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.

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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Active Ingredient                                               Purpose

Pyrithione Zinc             1.00%                            Anti-dandruff

Helps prevent to recurrence of flaking and itching associated with dandruff.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.
Avoid contact with eyes, if contact occurs rinse eyes with plenty of water.

shake well.

for maximum dandruff control, use every time you shampoo.

wet hair, squeeze small amount to palm, lather, rinse well for best results use at least twice a week or as directed by a doctor.

For external use only.

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

small amount to palm, or as directed by a doctor.

water, sodium laureth sulfate, sodium lauryl sulfate, glycol distearate, sodium chloride, zinc barbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine,  fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.

image of shampoo
MODESA 2 IN 1 DANDRUFF GREEN APPLE 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-433
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
ZINC SULFATE (UNII: 89DS0H96TB)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40104-433-01396.9 g in 1 PACKAGE; Type 0: Not a Combination Product04/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/02/2019
Labeler - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture(40104-433)

Revised: 4/2019
Document Id: 33d03bde-79ec-4da5-8f27-c578ec5d53ce
Set id: 2046de04-201c-42b2-986c-a39758a10f1a
Version: 1
Effective Time: 20190402
 
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.