MedPath

Everyday Clean Dandruff

Up & Up 153.008/153BD Everyday Clean Dandruff Shampoo

Approved
Approval ID

cc3df9d0-0c16-4176-99d7-d0aec2366f2c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 18, 2025

Manufacturers
FDA

Target Corporation

DUNS: 006961700

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 Code11673-153
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
pyrithione zinc
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (18)

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
SODIUM XYLENESULFONATEInactive
Code: G4LZF950UR
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
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PYRITHIONE ZINCActive
Quantity: 10 mg in 1 mL
Code: R953O2RHZ5
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/18/2025

Principal display panel

NDC 11673-153-11

Compare to Head & Shoulders ®Classic Clean Dandruff Shampoo*

Antidandruff Shampoo with 1% Pyrithione Zinc

Helps relieve dryness, itching and flaking associated with dandruff

Daily Clean

up & up™

22 FL OZ (1.37 PT) 651 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/18/2025

Use

helps prevent recurrence of flaking and itching associated with dandruff

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/18/2025

Adverse Reactions

Dist. by Target Corp., Mpls., MN 55403

Made in U.S.A. with U.S. and foreign components

TM & © 2025 Target Brands, Inc.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/18/2025

Questions?

Call 1-800-910-6874

WARNINGS SECTION

LOINC: 34071-1Updated: 9/18/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/18/2025

When using this product

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/18/2025

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, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/18/2025

Active ingredient

Pyrithione zinc 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/18/2025

Purpose

Anti-dandruff

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/18/2025

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/18/2025

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: 9/18/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/18/2025

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, dstributor of Head & Shoulders Classic Clean Dandruff Shampoo.

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Everyday Clean Dandruff - FDA Drug Approval Details