FDA.reportPublic FDA data

My Black is Beautiful Scalp Care Calming Scalp and Hair Lotion

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-07-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:29:07

Label at a glance#

ProductMy Black is Beautiful Scalp Care Calming Scalp and Hair
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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)?

OTC - QUESTIONS SECTION

1-844-227-7864

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 225 mL bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

MBIBMBIB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-462-222024-01-30C16284748780-1c7ccaba7-288c-fd44-e053-dadaa90aa01bMy Black is Beautiful Scalp Care Calming Scalp and Hair Lotion
69423-462-222022-08-24C16284748780-1c7ccaba7-288c-fd44-e053-dadaa90aa01bMy Black is Beautiful Scalp Care Calming Scalp and Hair Lotion
69423-462-222022-01-28C16284748780-1c7ccaba7-288c-fd44-e053-dadaa90aa01bMy Black is Beautiful Scalp Care Calming Scalp and Hair Lotion
69423-462-222021-11-14C16284748780-1c7ccaba7-288c-fd44-e053-dadaa90aa01bMy Black is Beautiful Scalp Care Calming Scalp and Hair Lotion
69423-462-222021-07-23C16284748780-1c7ccaba7-288c-fd44-e053-dadaa90aa01bMy Black is Beautiful Scalp Care Calming Scalp and Hair Lotion

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-46269423-462-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
METHYLPARABENA2I8C7HI9TIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLPARABENZ8IX2SC1OHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
QUATERNIUM-18O7757NO1VLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
NIACINAMIDE25X51I8RD4IACT
GREATER GALANGAL7Y64R856MBIACT
OLEYL ALCOHOL172F2WN8DVIACT
POLYSORBATE 60CAL22UVI4MIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYETHYLENE OXIDE 100000V46Y6OJ5QBIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1c5ad859-5900-56a3-e063-6394a90aa9a0a3bb4591-044e-a3e2-e053-2a95a90af5002024-07-03WarningsExact identifier
spl set id: a3bb4591-044e-a3e2-e053-2a95a90af500

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.