HEAD AND SHOULDERS PURELY GENTLE SCALP CARE 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, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, sodium xylenesulfonate, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodiumbenzoate, polyquaternium-10,magnesiumcarbonate hydroxide, benzyl alcohol, aloe barbadensis leaf juice,methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

3 Action

FORMULA

head &
shoulders ®

pyrithione zinc
dandruff shampoo + conditioner

2in 1

purely gentle scalp care

hypoallergenic, dye-free,
fragrance-free formula

with aloe vera

FLAKE FREE.*

UP TO 100%

GUARANTEED^

13.5 FL OZ
(400 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  PURELY GENTLE SCALP CARE 2IN1
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-075
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CETYL ALCOHOL (UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ZINC CARBONATE (UNII: EQR32Y7H0M)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-075-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	10/31/2020
2	NDC: 37000-075-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2013	10/31/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)