RxNorm Names

Review RxNorm Normal Forms

HEAD AND SHOULDERS DAMAGE RESCUE (pyrithione zinc) lotion/shampoo
[Procter & Gamble Manufacturing Co.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b7818ffe-9a5c-4cfe-b33c-350fbcf91be0

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-058
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (Pyrithione Zinc)	Pyrithione Zinc	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description
1	NDC:37000-058-42	420 mL in 1 BOTTLE, PLASTIC
2	NDC:37000-058-70	700 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	05/15/2012

Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 05/2012

Document Id: 79343ad6-f7e9-44f9-b04b-782472952aeb

Set id: b7818ffe-9a5c-4cfe-b33c-350fbcf91be0

Version: 1

Effective Time: 20120521

Procter & Gamble Manufacturing Co.

Daily Med

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