HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1- 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, sodium laureth sulfate, cocamideMEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, dimethicone, cocamidopropyl betaine, fragrance, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesiumcarbonate 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 + conditioner

ADVANCED

2in1

smooth & silky

24 hour frizz control from root to tip

FLAKE FREE.*

UP TO 100%

GUARANTEED^

12.8 FL OZ
(380 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  SMOOTH AND SILKY 2IN1
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-095
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)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-095-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	01/02/2017
2	NDC: 37000-095-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	11/10/2019
3	NDC: 37000-095-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2014	11/10/2019
4	NDC: 37000-095-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2014	03/01/2021
5	NDC: 37000-095-95	950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2016	11/10/2019
6	NDC: 37000-095-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2017
7	NDC: 37000-095-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2017
8	NDC: 37000-095-93	930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/11/2017
9	NDC: 37000-095-12	1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/29/2020

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)