RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=64a62348-610d-4043-ad43-b3b00d8b92a5

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 lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, cocamidopropyl betaine, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sea salt, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

head &
shoulders®

pyrithione zinc
dandruff shampoo

IMPROVES HAIR & SCALP
HEALTH GUARANTEED

ocean lift

with sea mineral essence,
invigorates hair and scalp

23.7 FL OZ
(700 mL)

99842192

Principal Display Panel - 700 mL Bottle Label

HEAD AND SHOULDERS OCEAN LIFT
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-788
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 lauryl sulfate
sodium laureth-3 sulfate
glycol distearate
zinc carbonate
sodium chloride
sodium xylenesulfonate
cocamidopropyl betaine
dimethicone
sodium benzoate
magnesium carbonate hydroxide
sea salt
methylchloroisothiazolinone
methylisothiazolinone
fd&c blue no. 1
fd&c yellow no. 5

Product Characteristics
Color	TURQUOISE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:37000-788-14	420 mL in 1 BOTTLE, PLASTIC
2	NDC:37000-788-23	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	01/01/2006

Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 01/2013

Document Id: 91cefe11-dc9e-4af6-abc3-6ff8cec7c2c9

Set id: 64a62348-610d-4043-ad43-b3b00d8b92a5

Version: 2

Effective Time: 20130116

Procter & Gamble Manufacturing Co.

Daily Med

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