Your browser does not support JavaScript! HEAD AND SHOULDERS EXTRA VOLUME (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]
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HEAD AND SHOULDERS EXTRA VOLUME (pyrithione zinc) lotion/shampoo
[Procter & Gamble Manufacturing Co.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Pyrithione zinc 1%

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, get medical 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.
  • shake before use.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

NEW
fresh scent
technology

head &
shoulders®

pyrithione zinc dandruff shampoo

extra volume

24 hour volume boost

FLAKE FREE.*
100%
GUARANTEED^

23.7 FL OZ
(700 mL)

96305397

Principal Display Panel - 700 mL Bottle Label
HEAD AND SHOULDERS   EXTRA VOLUME
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sodium lauryl sulfate 
sodium laureth-3 sulfate 
glycol distearate 
zinc carbonate 
sodium chloride 
sodium xylenesulfonate 
cocamidopropyl betaine 
dimethicone 
sodium benzoate 
magnesium carbonate hydroxide 
methylchloroisothiazolinone 
methylisothiazolinone 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-082-42420 mL in 1 BOTTLE, PLASTIC
2NDC:37000-082-70700 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H09/01/2013
Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 9/2013
 
Procter & Gamble Manufacturing Co.

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