Your browser does not support JavaScript! HEAD AND SHOULDERS DAMAGE RESCUE (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]
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HEAD AND SHOULDERS DAMAGE RESCUE (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.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, sodium laureth sulfate, sodium lauryl sulfate, dimethicone, cocamide MEA, zinc carbonate, glycol distearate, sodium xylenesulfonate, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, tocopheryl acetate, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, orange 4.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

head &
shoulders
®

pyrithione zinc
dandruff shampoo

LEAVES HAIR UP TO
10X STRONGER*

damage rescue

conditions to nourish damaged hair
helps relieve dry scalp

14.2 FL OZ (420 mL)

92212186

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label
HEAD AND SHOULDERS   DAMAGE RESCUE
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-058
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 Laureth-3 Sulfate 
Sodium Lauryl Sulfate 
Dimethicone 
Coco Monoethanolamide 
Zinc Carbonate 
Glycol Distearate 
Sodium Xylenesulfonate 
Cetyl Alcohol 
Magnesium Sulfate 
Sodium Chloride 
Sodium Benzoate 
Magnesium Carbonate Hydroxide 
Benzyl Alcohol 
.Alpha.-Tocopherol Acetate 
Methylchloroisothiazolinone 
Methylisothiazolinone 
FD&C Yellow No. 5 
D&C Orange No. 4 
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-058-42420 mL in 1 BOTTLE, PLASTIC
2NDC:37000-058-70700 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/15/2012
Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 5/2012
 
Procter & Gamble Manufacturing Co.

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