Head and Shoulders Dry Scalp Care: Package Insert and Label Information

HEAD AND SHOULDERS DRY SCALP CARE- 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.

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, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, sodium benzoate, guar hydroxypropyltrimonium chloride, dimethicone,TEA-dodecylbenzenesulfonate, magnesium carbonate hydroxide, trideceth-10, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 835mL Bottle Label

head &
shoulders _®
pyrithione zinc dandruff shampoo

DRY SCALP CARE
Daily Shampoo

CLINICALLY PROVEN TO HELP
RESTORE SCALP’S NATURAL MOISTURE
INFUSED WITH ALMOND OIL

FLAKE FREE.*
UP TO 100%
GUARANTEED^

28.2 FL OZ (835 mL)

HEAD AND SHOULDERS DRY SCALP CARE pyrithione zinc lotion/shampoo

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-092 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 g in 100 mL

Inactive Ingredients Ingredient Name Strength DIMETHICONOL GUM TRIDECETH-10 TRIETHANOLAMINE DODECYLBENZENESULFONATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) WATER SODIUM LAURETH-3 SULFATE SODIUM LAURYL SULFATE DIMETHICONE ZINC CARBONATE GLYCOL DISTEARATE SODIUM XYLENESULFONATE SODIUM CHLORIDE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE ALMOND OIL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE BENZYL ALCOHOL COCAMIDOPROPYL BETAINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37000-092-70 700 mL in 1 BOTTLE, PLASTIC None 2 NDC:37000-092-10 1000 mL in 1 BOTTLE, PLASTIC None 3 NDC:37000-092-40 400 mL in 1 BOTTLE, PLASTIC None 4 NDC:37000-092-25 250 mL in 1 BOTTLE, PLASTIC None 5 NDC:37000-092-95 950 mL in 1 BOTTLE, PUMP None 6 NDC:37000-092-71 700 mL in 1 BOTTLE, PLASTIC None 7 NDC:37000-092-01 2 BOTTLE, PUMP in 1 CELLO PACK contains a BOTTLE, PUMP 7 950 mL in 1 BOTTLE, PUMP This package is contained within the CELLO PACK (37000-092-01) 8 NDC:37000-092-37 370 mL in 1 BOTTLE, PLASTIC None 9 NDC:37000-092-61 613 mL in 1 BOTTLE, PLASTIC None 10 NDC:37000-092-83 835 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 09/01/2013

Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 02/2023 The Procter & Gamble Manufacturing Company