HEAD AND SHOULDERS NOURISHING HAIR AND SCALP CARE- pyrithione zinc shampoo
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Head and Shoulders ® Nourishing Hair and Scalp Care

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, dimethicone, cocamide MEA, zinc carbonate, glycol distearate, sodium xylenesulfonate, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, polyquaternium-10, benzyl alcohol, lavandula angustifolia (lavender) flower extract, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &

shoulders ®

pyrithione zinc dandruff shampoo

nourishing hair & scalp care
nourished hair from root to tip
with lavender

UP TO 100%

COLOR SAFE

FLAKE FREE*

12.8 FL OZ

(380 mL)

HEAD AND SHOULDERS NOURISHING HAIR AND SCALP CARE
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69423-091
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
CETYL ALCOHOL (UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69423-091-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016	12/10/2019
2	NDC:69423-091-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016	12/10/2019
3	NDC:69423-091-50	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016	10/13/2018
4	NDC:69423-091-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016	12/16/2019
5	NDC:69423-091-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2017	09/27/2022
6	NDC:69423-091-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2017	05/12/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	01/12/2016	09/27/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Name	Address	ID/FEI	Business Operations
Establishment
The Procter & Gamble Manufacturing Company		081329183	manufacture(69423-091)

Revised: 1/2022

Document Id: d66f23da-49cf-9990-e053-2a95a90a4df5

Set id: 029d67bb-6186-4c5e-8a2a-1d252a95215f

Version: 7

Effective Time: 20220125

The Procter & Gamble Manufacturing Company