Head and Shoulders ® Royal Oils Nighttime Scalp Tonic

Head and Shoulders Royal Oils Nighttime Scalp Tonic by

Drug Labeling and Warnings

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

Drug Details [pdf]

HEAD AND SHOULDERS ROYAL OILS NIGHTTIME SCALP TONIC- 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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Head and Shoulders ® Royal Oils Nighttime Scalp Tonic

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.

squeeze product directly onto exposed scalp & massage in slowly. Do not rinse.

Inactive ingredients

Water, mentha piperita (peppermint) leaf extract, mentha arvensis leaf oil, menthol, cannabis sativa seed oil, dimethicone, cetyl alcohol, stearyl alcohol, stearamidopropyl dimethylamine, cetearyl alcohol, quaternium-18, fragrance, hydroxyethylcellulose, PEG-2M, glyceryl stearate, oleyl alcohol, polysorbate 60, phenoxyethanol, citric acid, benzyl alcohol, propylparaben, methylparaben.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 100 mL bottle label

ROYAL OILS

by Head & Shoulders

PYRITHIONE ZINC DANDRUFF TREATMENT

NIGHTTIME SCALP

TONIC LOTION

WITH PEPPERMINT &

HEMP OIL

NOURISHES SCALP &

SOOTHES ITCH*

3.38 FL OZ (100 mL)

HEAD AND SHOULDERS ROYAL OILS NIGHTTIME SCALP TONIC 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-474
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
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
QUATERNIUM-18 (UNII: O7757NO1VL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-474-10	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/17/2020	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	11/17/2020	02/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2023

Document Id: fdb70fe0-c9fa-8628-e053-6394a90a328e

34390-5

Set id: b6ac1965-c724-e474-e053-2a95a90a6e47

Version: 2

Effective Time: 20230609

 

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