HEAD AND SHOULDERS DUAL PACK SMOOTH AND SILKY- pyrithione zinc kit

Head and Shoulders Dual Pack by

Drug Labeling and Warnings

Head and Shoulders 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

head &

shoulders

Smooth & Silky

pyrithione zinc dandruff shampoo

Drug Facts

Active ingredient

SHAMPOO: 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 lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

head &

shoulders
Smooth & Silky

pyrithione zinc dandruff 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, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Package

head &
shoulders ®

pyrithione zinc dandruff shampoo

smooth & silky

FLAKE FREE.*
UP TO 100%
COLOR SAFE

12.5 FL OZ (370 mL)

head &
shoulders ®

pyrithione zinc dandruff conditioner

smooth & silky

10.6 FL OZ (315 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS DUAL PACK  SMOOTH AND SILKY
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-749

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-749-01	1 in 1 CARTON; Type 0: Not a Combination Product	01/15/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	370 mL
Part 2	1 TUBE	315 mL

Part 1 of 2

HEAD AND SHOULDERS  SMOOTH AND SILKY
pyrithione zinc lotion/shampoo

Product Information
Item Code (Source)	NDC: 37000-094
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
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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	11/15/2022

Part 2 of 2

HEAD AND SHOULDERS CONDITIONER  SMOOTH AND SILKY
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 69423-103
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-103-31	315 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	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/15/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)