Label: ROYAL DANDRUFF DRY SCALP- pyrithione zinc shampoo

  • NDC Code(s): 73597-020-10
  • Packager: Mission Series Inc. dba Prestige Beauty Care
  • 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 May 1, 2023

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  • Active Ingredient

    Active Ingredient - Pyrithione Zinc 1%

  • Purpose

    Purpose

    Anti-dandruff

  • Use

    Use - helps protect the scalp's natural moisture balance and gives you great looking hair.

  • Warnings

    Warnings - For external use only.

  • When using this product

    When using this product

    - do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop Use

    Stop use and ask a doctor if

    - condition worsens or does not improve after regular use as directed.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    - 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.

  • Inactive Ingredients

    Inactive Ingredients - Water, Sodium Lauryl Ether Sulfate, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Cocomonoethanolamide, Ethylene Glycol Monostearate, Sodium Xylenesulfonate, Sodium Chloride, Zinc Carbonate, Dimethicone, Cetrimonium Chloride, Fragrance, Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis (sweet Almond) oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl. No. 42090

  • Distributed By

    Distributed By:

    PRESTIGE BEAUTY CARE

    1585 West Mission Blvd.

    Pomona, CA 91766

    Made in India

  • Royal Dandruff Shampoo Dry Scalp

    Royal Dandruff Dry Scalp

  • INGREDIENTS AND APPEARANCE
    ROYAL DANDRUFF DRY SCALP 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73597-020
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73597-020-10273.06 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/01/2023
    Labeler - Mission Series Inc. dba Prestige Beauty Care (117190866)
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