HEAD AND SHOULDERS CLASSIC CLEAN- pyrithione zinc 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]

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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, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33.

Questions (or comments)?

1-800-723-9569

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Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

3 Action

FORMULA

head &
shoulders ®
pyrithione zinc dandruff shampoo

classic clean
america's #1 dandruff shampoo**

FLAKE FREE.*
UP TO 100%
GUARANTEED^

23.7 FL OZ

(700 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  CLASSIC CLEAN
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-071
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
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-071-01	10 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/2013
2	NDC: 37000-071-50	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
3	NDC: 37000-071-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
4	NDC: 37000-071-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2013	10/04/2018
5	NDC: 37000-071-11	1180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2013	01/15/2019
6	NDC: 37000-071-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
7	NDC: 37000-071-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
8	NDC: 37000-071-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016
9	NDC: 37000-071-95	950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/10/2016
10	NDC: 37000-071-12	1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2017

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)