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 lauryl sulfate, glycol distearate, zinc carbonate, sodiumchloride, 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

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

head &

shoulders ®
pyrithione zinc dandruff shampoo

SMOOTH

& SILKY

DAILY SHAMPOO

24 hour frizz control from root to tip

UP TO 100%

COLOR SAFE +

DANDRUFF PROTECTION*

12.5 FL OZ
370 mL

HEAD AND SHOULDERS SMOOTH AND SILKY
pyrithione zinc lotion/shampoo

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-094-10	10 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/2013
2	NDC:37000-094-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	12/21/2019
3	NDC:37000-094-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	12/21/2019
4	NDC:37000-094-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017	02/28/2023
5	NDC:37000-094-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017	01/01/2025
6	NDC:37000-094-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017	01/01/2025
7	NDC:37000-094-50	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2020	08/30/2021
8	NDC:37000-094-37	370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2022
9	NDC:37000-094-61	613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M032	09/01/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Head and Shoulders ® Smooth and Silky