HEAD AND SHOULDERS ROYAL OILS DAILY MOISTURE SCALP- pyrithione zinc cream

Head and Shoulders Royal Oils Daily Moisture Scalp by

Drug Labeling and Warnings

Head and Shoulders Royal Oils Daily Moisture Scalp by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione zinc 0.1%

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

Apply to affected areas one to four times daily or as directed by a doctor.

Twist the cap open. Place tip directly onto scalp (damp or dry)

Gently squeeze the bottle while moving tip fromfront to back of your scalp. Repeat to cover your entire scalp.

Massage for even distribution. Do not rinse.

Inactive ingredients

Water, cocos nucifera (coconut) oil, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, stearyl alcohol, quaternium-18, hydroxyethylcellulose, phenoxyethanol, benzyl alcohol, dimethicone, PEG-2M, cetearyl alcohol, methylparaben, propylparaben, oleyl alcohol, glyceryl stearate, citric acid, polysorbate 60.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

head &
shoulders ®
pyrithione zinc dandruff treatment

ROYAL OILS

DAILY MOISTURE

SCALP CREAM

WITH COCONUT OIL

MOISTURIZES SCALP TO

PREVENT DRYNESS AND ITCH*

SULFATE, DYE &

MINERAL OIL FREE

5.0 FL OZ
(150 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS ROYAL OILS DAILY MOISTURE SCALP 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
QUATERNIUM-18 (UNII: O7757NO1VL)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCOL STEARATE (UNII: 0324G66D0E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-307-15	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/30/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)