HEAD AND SHOULDERS SMOOTH AND SILKY- pyrithione zinc lotion/shampoo

Head and Shoulders by

Drug Labeling and Warnings

Head and Shoulders 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

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, sodiumlaureth sulfate, zinc carbonate, glycol distearate, cocamide MEA, cocamidopropyl betaine, dimethicone, sodium xylenesulfonate, sodiumchloride, fragrance, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol,magnesium carbonate hydroxide, cetyl alcohol, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &

shoulders ®
pyrithione zinc dandruff shampoo

smooth & silky
24 hour frizz control from root to tip

UP TO 100%

COLOR SAFE +

FLAKE FREE.*

12.8 FL OZ
380 mL

INGREDIENTS AND APPEARANCE

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

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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
ZINC CARBONATE (UNII: EQR32Y7H0M)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
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	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
5	NDC: 37000-094-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017
6	NDC: 37000-094-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017

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

Labeler - The Procter & Gamble Manufacturing Company (004238200)