HEAD AND SHOULDERS CLINICAL DRY SCALP RESCUE KIT- pyrithione zinc kit

Head and Shoulders Clinical Dry Scalp Rescue Kit by

Drug Labeling and Warnings

Head and Shoulders Clinical Dry Scalp Rescue Kit 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

head & shoulders
CLINICAL STRENGTH SHAMPOO

DANDRUFF DEFENSE

DRY SCALP RESCUE

Drug Facts

Active ingredient

Selenium Sulfide 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

sodium lauryl sulfate, glycol distearate, sodiumchloride, cocamidopropyl betaine, sodiumcitrate, sodiumxylenesulfonate, fragrance, dimethicone, citric acid, sodium benzoate, tetrasodiumEDTA, hydroxypropylmethylcellulose, honey extract, red 4.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

head & shoulders
CLINICAL STRENGTH CONDITIONER

DANDRUFF DEFENSE

DRY SCALP RESCUE

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,sodium chloride, citric acid, honey extract, 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

head & shoulders ®

selenium sulfide dandruff & soborrheic dermatitis shampoo

CLINICAL STRENGTH

DANDRUFF DEFENSE

DRY SCALP

RESCUE

head & shoulders ®

pyrithione zinc dandruff conditioner

CLINICAL STRENGTH

DANDRUFF DEFENSE

DRY SCALP

RESCUE

1 SELENIUM SULFIDE DANDRUFF & SEBORRHEIC DERMATITIS

SHAMPOO 13.5 FL OZ (400 mL)

1 PYRITHIONE ZINC DANDRUFF

CONDITIONER 9.1 FL OZ (270 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS CLINICAL DRY SCALP RESCUE KIT 
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-673

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-673-01	1 in 1 PACKAGE, COMBINATION	03/15/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	400 mL
Part 2	1 TUBE	270 mL

Part 1 of 2

HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE DRY SCALP RESCUE 
selenium sulfide lotion/shampoo

Product Information
Item Code (Source)	NDC: 69423-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HONEY (UNII: Y9H1V576FH)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-523-40	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	03/15/2023

Part 2 of 2

HEAD AND SHOULDERS CLINICAL DANDRUFF DEFENSE DRY SCALP RESCUE 
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 69423-568
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
HONEY (UNII: Y9H1V576FH)
COCONUT (UNII: 3RT3536DHY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-568-27	270 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	01/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/15/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)