HEAD AND SHOULDERS INSTANT RELIEF- pyrithione zinc lotion/shampoo
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Head and Shoulders ®

Instant Relief

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, zinc carbonate, glycol distearate, cocamideMEA, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesiumcarbonate hydroxide, cetyl alcohol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow5, blue 1.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff shampoo

INSTANT

RELIEF

DAILY SHAMPOO

cooling scalp relief

infused with peppermint complex
& tea tree essence

FLAKE FREE.*
UP TO 100%
GUARANTEED^

12.8 FL OZ (380 mL)

HEAD AND SHOULDERS INSTANT RELIEF
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-341
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)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-341-10	10 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/2014	08/14/2022
2	NDC:37000-341-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	08/14/2022
3	NDC:37000-341-66	665 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	12/01/2020
4	NDC:37000-341-23	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2016	01/31/2019
5	NDC:37000-341-93	930 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/11/2017	09/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	09/01/2014	08/14/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2022

Document Id: dc66d6b2-d081-5048-e053-2a95a90ae57d

Set id: c0ff35ca-dca2-4617-a086-c0e0dc27c01c

Version: 9

Effective Time: 20220411

The Procter & Gamble Manufacturing Company

Head and Shoulders ® Instant Relief