Label: ROYAL DANDRUFF DRY SCALP CARE- 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 September 17, 2013

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  • 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)
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