MedPath

Dry Scalp

Best Choice 281.007/281AK,AN Dandruff Shampoo, Dry Scalp

Approved
Approval ID

6349fd91-675b-4489-8b57-e584f718ca3f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Valu Merchandisers Co.

DUNS: 868703513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pyrithione zinc

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63941-952
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pyrithione zinc
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (17)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ZINC CARBONATEInactive
Code: EQR32Y7H0M
Classification: IACT
AMODIMETHICONE (800 CST)Inactive
Code: 363Z2T48P7
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)Inactive
Code: B16G315W7A
Classification: IACT
MAGNESIUM CARBONATE HYDROXIDEInactive
Code: YQO029V1L4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
PYRITHIONE ZINCActive
Quantity: 10 mg in 1 mL
Code: R953O2RHZ5
Classification: ACTIB
SODIUM XYLENESULFONATEInactive
Code: G4LZF950UR
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

Principal display panel

Best Choice ®

COMPARE TO THE ACTIVE INGREDIENT IN HEAD & SHOULDERS ®*

DRY SCALP

DANDRUFF

SHAMPOO

Pyrithione Zinc

Dandruff Shampoo

12.5 FL OZ (370 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Use

helps prevent recurrence of flaking and itching associated with dandruff

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/12/2025

Adverse Reactions

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KS 66106

Scan here for more product information.

Call 1-844-292-1112 for more product information.

Best Choice ®

100% Guaranteed

www.bestchoicebrand.com

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

inactive ingredients

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/12/2025

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Dry Scalp Care.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Active ingredient

Pyrithione zinc 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Purpose

Anti-dandruff

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/12/2025

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

Directions

  • 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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/12/2025

Questions?

Call 1-888-593-0593

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