Royal Oils by Head and Shoulders ® Moisturing Hair & Scalp Co-Wash

Royal Oils by Head and Shoulders Moisturizing Hair and Scalp Co-Wash by

Drug Labeling and Warnings

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

Drug Details [pdf]

ROYAL OILS BY HEAD AND SHOULDERS MOISTURIZING HAIR AND SCALP CO-WASH- pyrithione zinc lotion 
The Procter & Gamble Manufacturing Company

Disclaimer: 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.

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Royal Oils by Head and Shoulders ® Moisturing Hair & Scalp Co-Wash

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.
• wet hair,massaging into hair and scalp. Expect low lather. Rinse, repeat if desired

Inactive ingredients

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, cocos nucifera (coconut) oil, fragrance, glutamic acid, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 450 mL Bottle Label

ROYAL OILS by

head &
shoulders ®
pyrithione zinc dandruff Co-Wash

MOISTURIZING

HAIR & SCALP

CO-WASH

WITH COCONUT OIL

CLEANSES SCALP

AND DETANGLES

FOR CURLY & COILY CROWNS

15.2 FL OZ
(450 mL)

ROYAL OILS BY HEAD AND SHOULDERS MOISTURIZING HAIR AND SCALP CO-WASH 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-576
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
GLUTAMIC ACID (UNII: 3KX376GY7L)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-576-45	450 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/20/2021	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	01/20/2021	09/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 7/2023

Document Id: ffd85a45-d9d4-255f-e053-6294a90aad85

34390-5

Set id: d83cf17b-a183-fc3a-e053-2995a90a0b47

Version: 3

Effective Time: 20230706

 

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