Label: MODESA 2 IN 1 DANDRUFF GREEN APPLE- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated April 2, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient                                               Purpose

    Pyrithione Zinc             1.00%                            Anti-dandruff

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • INDICATIONS & USAGE

    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.

  • WARNINGS

    For external use only.

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

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    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.

  • PRINCIPAL DISPLAY PANEL

    image of shampoo
  • INGREDIENTS AND APPEARANCE
    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)
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