Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Use

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

Warnings

For external use only

Ask a doctor before use if

condition covers a large area of the body

When using this product

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

Stop use and ask a doctor if

condition worsens or does not improve after regular use as directed

Keep out of reach of children.

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

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 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

adverse reaction

*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

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 description

DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72476-816
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72476-816-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	08/18/2021

Labeler - Retail Business Services, LLC (967989935)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(72476-816)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(72476-816)

Name	Address	ID/FEI	Business Operations
Establishment
RWM TECHNOLOGIES LLC		626626969	manufacture(72476-816)

Advanced Solution Dandruff ShampooCare One 816.000 816AC/AD