ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK- pyrithione zinc kit

Royal Oils by Head and Shoulders Scalp Care Dual Pack by

Drug Labeling and Warnings

Royal Oils by Head and Shoulders Scalp Care Dual Pack 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

ROYAL OILS

by head & shoulders
SULFATE FREE

SCALP CARE

SHAMPOO

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.
• shake before use.
• wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium citrate, fragrance, sodium chloride, cocos nucifera (coconut) oil, vinegar†, acrylates copolymer, polyquaternium-10, dimethiconol, sodium benzoate, citric acid, sodium salicylate.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

ROYAL OILS

by head & shoulders
MOISTURE RENEWAL SCALP BALANCING CONDITIONER

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.
• apply to wet hair after shampooing by gently massaging 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

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit

ROYAL OILS

by head & shoulders ®

Shampoo & Conditioner Inside

pyrithione zinc dandruff shampoo

ROYAL OILS

by head & shoulders

SULFATE FREE

SCALP CARE

SHAMPOO

ROYAL OILS

by head & shoulders

pyrithione zinc dandruff conditioner

MOISTURE RENEWAL

SCALP BALANCING

CONDITIONER

1 PYRITHIONE ZINC DANDRUFF

SHAMPOO 12.8 FL OZ (380 mL)

1 PYRITHIONE ZINC DANDRUFF

CONDITIONER 13.5 FL OZ (400 mL)

INGREDIENTS AND APPEARANCE

ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK 
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-003-01	1 in 1 CELLO PACK	05/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	380 mL
Part 2	1 BOTTLE, PLASTIC	400 mL

Part 1 of 2

ROYAL OILS BY HEAD AND SHOULDERS SULFATE FREE SCALP CARE 
pyrithione zinc shampoo

Product Information
Item Code (Source)	NDC: 69423-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONOL (50000 CST) (UNII: R2285D73YT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-608-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Part 2 of 2

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

Product Information
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
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCONUT (UNII: 3RT3536DHY)
CORN SILK (UNII: 7D3VB244UX)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
ACETIC ACID (UNII: Q40Q9N063P)

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	05/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)