Label: MY BLACK IS BEAUTIFUL SCALP CARE CALMING SCALP AND HAIR- pyrithione zinc lotion

  • NDC Code(s): 69423-462-22
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 July 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

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

  • Directions

    • Section hair as needed
    • Place nozzle onto the scalp (damp or dry), squeeze pump and apply to cover entire scalp. Massage to evenly distribute. Do not rinse.
    • Apply to affected areas 1-4 times daily or as directed by a doctor.

  • Inactive ingredients

    Water, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, stearyl alcohol, hydroxyethylcellulose, quaternium-18, phenoxyethanol, benzyl alcohol, dimethicone, PEG-2M, cetearyl alcohol, methylparaben, glyceryl stearate, oleyl alcohol, propylparaben, citric acid, polysorbate 60, aloe barbadensis leaf juice, panthenol, niacinamide, alpinia galanga rhizome extract.

  • Questions (or comments)?

    1-844-227-7864

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 225 mL bottle

    my black

    is beautiful

    SCALP CARE

    Pyrithione Zinc

    dandruff treatment

    MBIB

    beautiful

    calming

    SCALP & HAIR LOTION

    blue ginger with aloe vera

    7.6 FL OZ (225 mL)

    MBIB

  • INGREDIENTS AND APPEARANCE
    MY BLACK IS BEAUTIFUL SCALP CARE CALMING SCALP AND HAIR 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-462
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-462-22225 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03204/01/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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