RxNorm Names

Review RxNorm Normal Forms

HEAD AND SHOULDERS BREAKAGE PREVENTION (pyrithione zinc) shampoo
[ALL NATURAL DYNAMICS]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35efb2a7-b707-4fe1-9a45-0b280aac7618

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.

helps prevent hair loss

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, Coco Monoethanolamide, Zinc carbonate, Glycol distearate, Dimethicone, Guar hydroxypropyltrimonium chloride, Magnesium sulfate, Sodium benzoate, Magnesium carbonate hydroxide, Benzyl alcohol, Tocopheryl acetate, FD&C Yellow No. 5, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue no. 1

Questions (or comments)?

01-800-717-2413

Dist. by

Procter & Gamble Manufactura, S. de R.L. de C.V.

San Andr`s Atoto No. 326, Naucalpan de Juarez,

Estado de Mexico, MX

www.headandshoulders.com

image description

HEAD AND SHOULDERS BREAKAGE PREVENTION
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51769-141
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (PYRITHIONE ZINC)	Pyrithione Zinc	0.01 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Sodium laureth sulfate
Sodium lauryl sulfate
Coco Monoethanolamide
Zinc carbonate
Glycol distearate
Dimethicone
Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)
Magnesium sulfate
Sodium benzoate
magnesium carbonate hydroxide
Benzyl alcohol
.ALPHA.-TOCOPHEROL ACETATE
FD&C Yellow No. 5
methylchloroisothiazolinone
methylisothiazolinone
FD&C Blue no. 1

Packaging
#	Item Code	Package Description
1	NDC:51769-141-50	500 mL in 1 BOTTLE, PLASTIC
2	NDC:51769-141-40	400 mL in 1 BOTTLE, PLASTIC
3	NDC:51769-141-20	200 mL in 1 BOTTLE, PLASTIC
4	NDC:51769-141-11	1000 mL in 1 BOTTLE, PLASTIC
5	NDC:51769-141-18	1180 mL in 1 BOTTLE, PLASTIC
6	NDC:51769-141-05	50 mL in 1 BOTTLE, PLASTIC
7	NDC:51769-141-01	10 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/01/2013

Labeler - ALL NATURAL DYNAMICS (962732892)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		812807550	manufacture(51769-141)

Revised: 02/2013

Document Id: f58016ec-c5ab-4943-bd2b-e85b04fac313

Set id: 35efb2a7-b707-4fe1-9a45-0b280aac7618

Version: 1

Effective Time: 20130201

ALL NATURAL DYNAMICS

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