FDA.reportPublic FDA data

Care One 816.000 816AC/AD Advanced Solution Dandruff Shampoo

Manufacturer
Retail Business Services, LLC | Consumer Product Partners, LLC | RWM TECHNOLOGIES LLC
Effective date
2024-09-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:55:30

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

CAREONE

Compare to Head & Shoulders

Clinical Strength Dandruff Shampoo

DANDRUFF

SHAMPOO

MAXIMUM STRENGTH

  • Regular use helps control dandruff flaking
  • No Phthalates
  • No Parabens

NET 14.2 FL OZ (420 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-816DANDRUFF (SELENIUM SULFIDE) SHAMPOO [RETAIL BUSINESS SERVICES, LLC]6Legacy NDC20240907_eb4dbc0a-83f1-41c9-b20f-e1321ddbb0cd.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-81672476-816-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMMONIUM LAURETH-3 SULFATE896SJ235FNIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
GLYCOL DISTEARATE13W7MDN21WIACT
COCO MONOETHANOLAMIDEC80684146DIACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
SODIUM CITRATE1Q73Q2JULRIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
HYPROMELLOSES3NXW29V3WOIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SELENIUM SULFIDEZ69D9E381QACTIB

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
37b5bbc0-5ad2-f80b-e063-6394a90ac50eeb4dbc0a-83f1-41c9-b20f-e1321ddbb0cd2025-06-16Warnings, Adverse reactionsExact identifier
spl set id: eb4dbc0a-83f1-41c9-b20f-e1321ddbb0cd

Reported adverse events (FAERS/openFDA)#

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