HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE ITCH RELIEF- selenium sulfide lotion/shampoo 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Head and Shoulders ®

Clinical Strength Dandruff Defense Intensive Itch Relief Shampoo

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpose

Anti-dandruff, anti-seborrheic dermatitis

Uses

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

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

avoid contact with 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 of this product as directed

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

head &

shoulders ®

selenium sulfide dandruff &

seborrheic dermatitis shampoo

Clinical Strength

Dandruff Defense

Intensive

Itch Relief

13.5 FL OZ (400 mL)

HS

HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE ITCH RELIEF 
selenium sulfide lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-526
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69423-526-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/17/2020
2NDC:69423-526-012 in 1 CELLO PACK01/17/2023
2400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03211/17/2020
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 5/2023
Document Id: fb36d298-b693-6731-e053-6394a90adc44
Set id: b6ad7707-9d02-31a6-e053-2a95a90ae7ad
Version: 3
Effective Time: 20230508
 
The Procter & Gamble Manufacturing Company