RxNorm Names

Review RxNorm Normal Forms

HEAD AND SHOULDERS DRY SCALP (pyrithione zinc) lotion/shampoo
[Procter & Gamble Manufacturing Co]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c23dc070-87f4-480f-b04b-967e42462ddb

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

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, cetyl alcohol, polyquaternium-10, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate.

Questions (or comments)?

1-800-723-9569

www.headandshoulders.com
Made in U.S.A. of US and/or imported ingredients.
Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 420mL Bottle Label

head &
shoulders®
pyrithione zinc
dandruff shampoo

IMPROVES HAIR & SCALP
HEALTH GUARANTEED

dry scalp care
with moisturizers,
relieves dry scalp and itch

14.2 FL OZ (420mL)

Principal Display Panel - 420mL Bottle Label

HEAD AND SHOULDERS DRY SCALP
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-781
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
water
sodium laureth-3 sulfate
sodium lauryl sulfate
Coco Monoethanolamide
zinc carbonate
glycol distearate
dimethicone
cetyl alcohol
magnesium sulfate
sodium benzoate
magnesium carbonate hydroxide
benzyl alcohol
sodium chloride
methylchloroisothiazolinone
methylisothiazolinone
sodium xylenesulfonate

Product Characteristics
Color	TURQUOISE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:37000-781-14	420 mL in 1 BOTTLE, PLASTIC
2	NDC:37000-781-23	700 mL in 1 BOTTLE, PLASTIC
3	NDC:37000-781-33	1000 mL in 1 BOTTLE, PLASTIC
4	NDC:37000-781-40	1180 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2006

Labeler - Procter & Gamble Manufacturing Co (004238200)

Revised: 01/2013

Document Id: 246ba94b-2f14-48ad-962c-5fb9fac1361c

Set id: c23dc070-87f4-480f-b04b-967e42462ddb

Version: 3

Effective Time: 20130115

Procter & Gamble Manufacturing Co

Daily Med

Current Medication Information

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