Advanced Solution Dandruff Shampoo 816.000/816AD

Manufacturer
Vi-Jon, LLC | RWM TECHNOLOGIES LLC
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 21:40:34

Label at a glance#

ProductDandruff
Active ingredientSELENIUM SULFIDE
Label structure12 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 if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-seborrheic dermatitis

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

condition covers a large area of the body

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

adverse reaction

ADVERSE REACTIONS SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Clinical Strength Dandruff Shampoo.

Manufactured by:  Vi-Jon, LLC., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA with US and foreign parts.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

*compare to Head

& Shoulders

Maximum

srength

helps fight dandruff from the 1st wash

helps relieve even stubborn dandruff

helps prevent flakes

dandruff

shampoo

dandruff and seborreic

dermatitis and shampoo

- with selenium sulfide

advanced solution

14.2 FL OZ (420 mL)

image descriptionimage description

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-08160869-0816-21, 0869-0816-15, 0869-0816-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
10d1ba9f-c2fd-2bde-e063-6294a90a59d939e97583-644d-4a37-8104-e87704a89e922024-02-07Warnings, Adverse reactionsExact identifier
spl set id: 39e97583-644d-4a37-8104-e87704a89e92

Reported adverse events (FAERS/openFDA)#

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