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Dandruff

HEB 816.000/816AC-AD Advanced Solution Dandruff Shampoo

Approved
Approval ID

182ca790-0713-412a-9111-c0cf40f20d02

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

HEB

DUNS: 007924756

Products 1

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

Selenium sulfide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37808-816
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Selenium sulfide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (20)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIUM LAURETH-3 SULFATEInactive
Code: 896SJ235FN
Classification: IACT
AMMONIUM LAURYL SULFATEInactive
Code: Q7AO2R1M0B
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT
COCO MONOETHANOLAMIDEInactive
Code: C80684146D
Classification: IACT
AMMONIUM XYLENESULFONATEInactive
Code: 4FZY6L6XCM
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
AMODIMETHICONE (800 CST)Inactive
Code: 363Z2T48P7
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROGEN PEROXIDEInactive
Code: BBX060AN9V
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C RED NO. 4Inactive
Code: X3W0AM1JLX
Classification: IACT
SELENIUM SULFIDEActive
Quantity: 10 mg in 1 mL
Code: Z69D9E381Q
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

principal display panel

H-E-B ®

DANDRUFF SHAMPOO

With Selenium Sulfide

INTENSIVE TREATMENT

MAXIMUM STRENGTH

RELIEVES DRY SCALP AND ITCH

Leaves Hair Healthy Looking & Fights Dry Scalp

14.2 FL OZ (420 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

Use

helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/23/2025

ADVERSE REACTION

MADE WITH PRIDE AND CARE FOR H-E-B ®, SAN ANTONIO, TX 78204

100% GUARANTEE promise - If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.

You have our word on it.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/23/2025

Claim

INTENSIVE TREATMENT

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredient

Selenium sulfide 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

Warnings

For external use only

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/23/2025

Ask a doctor before use if

condition covers a large area of the body

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/23/2025

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/23/2025

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: 9/23/2025

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: 9/23/2025

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
  • if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, amodimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydrogen peroxide, hydroxypropyl methylcellulose, methylchlorisothiazolinone, methylisothiazolinone, red 4

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

Questions

1-888-593-0593

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