Label: MY BLACK IS BEAUTIFUL SCALP CARE COOLING SCALP SERUM- pyrithione zinc liquid

  • NDC Code(s): 69423-463-40
  • 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 January 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • Purpose

    Anti-dandruff

  • Use

    reduces the symptoms of 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
    • Squeeze 1-2 drops directly on affected area of scalp, massage for even distribution. Do not rinse.
    • Apply to affected areas 1-4 times daily or as directed by a doctor.

  • Inactive ingredients

    Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, benzyl alcohol, menthol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, mentha piperita (peppermint) oil, mentha arvensis leaf oil, alpinia galanga rhizome extract.

  • Questions (or comments)?

    1-844-227-7864

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 40 mL bottle

    my black

    is beautiful

    SCALP CARE

    Pyrithione Zinc

    dandruff treatment

    MBIB

    beautiful

    cooling

    SCALP SERUM

    blue ginger with mint

    1.3 FL OZ (40 mL)

    MBIB

  • INGREDIENTS AND APPEARANCE
    MY BLACK IS BEAUTIFUL SCALP CARE COOLING SCALP SERUM 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-463
    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
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    CAFFEINE (UNII: 3G6A5W338E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EDETOL (UNII: Q4R969U9FR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-463-4040 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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