Head and Shoulders Extra Strength Men

Dosage form: lotion/shampoo
Ingredients: Pyrithione Zinc 2g in 100mL
Labeler: Procter & Gamble Manufacturing Co.
NDC Code: 37000-062

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.

Head and Shoulders®
Extra Strength Men

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

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, getmedical help or contact a Poison Control Center right away.

Directions
  • for best results use at least twice a week or as directed by a doctor.
  • for maximum dandruff control, use every time you shampoo.
  • wet hair, massage onto scalp, rinse, repeat if desired.
  • shake before use.

Inactive ingredients

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, sodium xylenesulfonate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 4.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

2x
THE ACTIVE
INGREDIENT††

head &
shoulders
®

pyrithione zinc dandruff shampoo

MEN

EXTRA STRENGTH

2% pyrithione zinc

powerful relief starts at the 1st wash

13.5 FL OZ (400 mL)

96905875

HEAD AND SHOULDERS   EXTRA STRENGTH MEN
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-062
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Laureth-3 Sulfate 
Sodium Lauryl Sulfate 
Coco Monoethanolamide 
Zinc Carbonate 
Glycol Distearate 
Sodium Xylenesulfonate 
Dimethicone 
Cetyl Alcohol 
Magnesium Sulfate 
Sodium Chloride 
Sodium Benzoate 
Magnesium Carbonate Hydroxide 
Benzyl Alcohol 
Methylchloroisothiazolinone 
Methylisothiazolinone 
FD&C Blue No. 1 
FD&C Red No. 4 
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) 
Packaging
#Item CodePackage Description
1NDC:37000-062-40400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/23/2012
Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 08/2014
 
Procter & Gamble Manufacturing Co.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)