HEAD AND SHOULDERS CLINICAL STRENGTH- 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 &

shoulders

clinical strength

selenium sulfide dandruff 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.

When using this product

  • 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

  • caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.
  • for best results use at least twice a week or as directed by a doctor.
  • for maximum dandruff control, use every time you shampoo.
  • shake before use.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, sisodiumEDTA, sodium laureth sulfate, hydroxypropyl methylcellulose, camphor, eucalyptol, methylchloroisothiazolinone, methylisothiazolinone, red 4.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

www.headandshoulders.com

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

head &

shoulders ®

selenium sulfide dandruff
and seborrheic dermatitis shampoo

clinical strength

clinically proven relief for severe dandruff

13.5 FL OZ (400 mL)

HS

HEAD AND SHOULDERS  CLINICAL STRENGTH
selenium sulfide lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-330
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
EUCALYPTOL (UNII: RV6J6604TK)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-330-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201011/19/2022
2NDC:37000-330-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/201710/22/2022
3NDC:37000-330-012 in 1 CELLO PACK11/09/201810/22/2022
3400 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 finalpart358H07/01/201011/19/2022
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2022
Document Id: d60a96f2-4e8d-099a-e053-2a95a90a21aa
Set id: 83cb18cf-627f-4616-92d0-09cbebbc6d1d
Version: 7
Effective Time: 20220120
 
The Procter & Gamble Manufacturing Company