ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER- pyrithione zinc lotion

Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner by

Drug Labeling and Warnings

Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner 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 0.5%

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.
• gently massage into hair and scalp, rinse well.

Inactive ingredients

Water, stearyl alcohol, dimethicone, behentrimonium chloride, cetyl alcohol, cocos nucifera (coconut) fruit extract, vinegar, zea mays (corn) silk extract, fragrance, phenoxyethanol, benzyl alcohol, citric acid, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

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Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

ROYAL OILS

by head & shoulders ®
pyrithione zinc dandruff conditioner

MOISTURE RENEWAL

SCALP BALANCING

CONDITIONER

ROYAL OILS

WITH COCONUT OIL

& APPLE CIDER VINEGAR

13.5 FL OZ
(400 mL)

INGREDIENTS AND APPEARANCE

ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-571
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)
CORN SILK (UNII: 7D3VB244UX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCONUT (UNII: 3RT3536DHY)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-571-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021
2	NDC: 69423-571-93	930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	05/01/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)