FDA.reportPublic FDA data

Dry Scalp Care

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:44:08

Label at a glance#

ProductDry Scalp Care
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Dosage and administration

shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

QUALITY GUARANTEED

This TopCare ®product is laboratory tested to guarantee its highest quality.

Your total satisfaction is quaranteed.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use as directed

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • for maximum dandruff control, use every time you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Adverse reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL. 60143

©TOPCO VIJA1023

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Heard & Shoulders ®Dry Scalp Care 2in1 Dandruff Shampoo + Conditioner.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®beauty

2-IN-1

DRY SCALP

DANDRUFF SHAMPOO + CONDITIONER

with Pyrithione Zinc

Compare to HEAD & SHOULDERS ®*

with Almond Oil

Helps prevent flakes

Cleans & conditions hair in one step

Conditioning formula to help balance natural scalp moisture

12.5 FL OZ (370 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN16
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD16
209884zinc pyrithione 1 % Medicated ConditionerSY16
209884zinc pyrithione 1 % Medicated ShampooSY16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-497-15Dry Scalp Care420 mL in 1 BOTTLE, PLASTICSHAMPOO42016
36800-497-32Dry Scalp Care370 mL in 1 BOTTLE, PLASTICSHAMPOO37016

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-49736800-497-15, 36800-497-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALMOND OIL66YXD4DKO9IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152026-01-19monthly-update2026-06-03 17:52:58

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
Dry Scalp CarePYRITHIONE ZINCTopco Associates LLC3300bfd5-ae84-4bc8-a4cd-05472b498fb72026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-497-32
ndc (package): 36800-497-15
ndc (product): 36800-497
ndc11 (package): 36800049715
ndc11 (package): 36800049732
spl id: 4ab84ad5-aa8e-5ee0-e063-6294a90a29fa
spl set id: 3300bfd5-ae84-4bc8-a4cd-05472b498fb7

Reported adverse events (FAERS/openFDA)#

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