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

Head and Shoulders Dual Sachets by

Drug Labeling and Warnings

Head and Shoulders Dual Sachets 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
instant relief
pyrithione zinc dandruff 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, cocamide MEA, zinc carbonate, glycol distearate, fragrance, sodium xylenesulfonate, dimethicone, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

head &
shoulders
instant relief
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, fragrance, dimethicone, glutamic acid, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.

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

24 hour frizz control from root to tip

FLAKE FREE.*
UP TO 100%
COLOR SAFE

0.34 FL OZ (10 mL)

head &
shoulders ®

pyrithione zinc dandruff conditioner

smooth & silky

24 hour frizz control from root to tip

0.34 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS DUAL SACHETS  SMOOTH AND SILKY
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-296

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-296-01	1 in 1 PACKAGE, COMBINATION	09/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	10 mL
Part 2	1 POUCH	10 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
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-094-10	10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2013

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
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-103-10	10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)