Label: ROYAL DANDRUFF DRY SCALP CARE- pyrithione zinc shampoo

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                     Purpose

    Pyrithione Zinc       1%                            Anti-dandruff

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  • PURPOSE

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

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  • 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.

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  • 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.

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  • WARNINGS

    For external use only.

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

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  • DOSAGE & ADMINISTRATION

    apply as needed.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ROYAL DANDRUFF DRY SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50438-300
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    cocamidopropyl betaine  
    glycol stearate  
    CARBOMER COPOLYMER TYPE A  
    ammonium chloride  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    CITRIC ACID MONOHYDRATE  
    EDETATE DISODIUM  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50438-300-01 350 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 09/17/2013
    Labeler - Filo America (943873703)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    Name Address ID/FEI Business Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265 manufacture(50438-300)
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