Head and Shoulders MEN Advanced Series Bourbon 2in1: Package Insert and Label Information

HEAD AND SHOULDERS MEN ADVANCED SERIES BOURBON 2IN1- 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, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride, fragrance, dimethicone, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76, bourbon extract, methylchloroisothiazolinone, methylisothiazolinone, blue1, red33.

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 + conditioner

2in1

MEN

ADVANCED SERIES

BOURBON

12.8 FL OZ

(380 mL)

HSHS
HEAD AND SHOULDERS MEN ADVANCED SERIES BOURBON 2IN1
pyrithione zinc lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-412
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
COCO MONOETHANOLAMIDE
CETYL ALCOHOL
D&C RED NO. 33
WATER
SODIUM LAURYL SULFATE
SODIUM LAURETH-3 SULFATE
GLYCOL DISTEARATE
ZINC CARBONATE
SODIUM CHLORIDE
SODIUM XYLENESULFONATE
COCAMIDOPROPYL BETAINE
SODIUM BENZOATE
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MAGNESIUM CARBONATE HYDROXIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
STEARYL ALCOHOL
BOURBON WHISKEY EXTRACTIVES
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69423-412-38 380 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 11/21/2019
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 01/2020 The Procter & Gamble Manufacturing Company

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