HEAD AND SHOULDERS DRY SCALP CARE DUAL PACK- pyrithione zinc kit

Head and Shoulders Dry Scalp Care Dual Pack by

Drug Labeling and Warnings

Head and Shoulders Dry 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

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, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, sodium benzoate, guar hydroxypropyltrimonium chloride, dimethicone, TEA-dodecylbenzenesulfonate, magnesium carbonate hydroxide, trideceth-10, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

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, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit

head & shoulders ®

Shampoo & Conditioner Inside

head & shoulders

pyrithione zinc dandruff shampoo

DRY SCALP CARE

DAILY SHAMPOO

head & shoulders

pyrithione zinc dandruff conditioner

DRY SCALP CARE DAILY HAIR & SCALP

CONDITIONER

1 PYRITHIONE ZINC DANDRUFF

SHAMPOO 12.5 FL OZ (370 mL)

1 PYRITHIONE ZINC DANDRUFF

CONDITIONER 10.9 FL OZ (325 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS DRY SCALP CARE DUAL PACK 
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-077

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-077-01	1 in 1 CARTON	01/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	370 mL
Part 2	1 TUBE	325 mL

Part 1 of 2

HEAD AND SHOULDERS  DRY SCALP CARE
pyrithione zinc lotion/shampoo

Product Information
Item Code (Source)	NDC: 37000-092
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
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONOL (50000 CST) (UNII: R2285D73YT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
TRIDECETH-10 (UNII: G624N6MSBA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-092-37	370 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	09/01/2013

Part 2 of 2

HEAD AND SHOULDERS DRY SCALP CARE  HAIR AND SCALP CONDITIONER
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 69423-160
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 (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLUTAMIC ACID (UNII: 3KX376GY7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-160-32	325 mL in 1 TUBE; 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	11/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)