ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]

ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]
PDF | XML

NDC 50438-300-01
Set ID 73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Active Ingredient                                     Purpose

    Pyrithione Zinc       1%                            Anti-dandruff

  • PURPOSE

    Help prevent the scalp's natural moisture balance and gives you great looking hair.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • INDICATIONS & USAGE

    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.

  • 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

    apply as needed.

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ROYAL DANDRUFF DRY SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    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:50438-300-01350 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/17/2013
    Labeler - Filo America (943873703)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture(50438-300)

Related Drugs