HEAD AND SHOULDERS ITCH- selenium sulfide shampoo

Head and Shoulders Itch by

Drug Labeling and Warnings

Head and Shoulders Itch 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

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

for the relief of scalp itch, irritation, redness and flaking associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

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 OR PRIOR TO USE IN CHILDREN UNDER 2 YEARS.

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. Leave on for several minutes. Rinse. Repeat if desired.

Inactive Ingredients

Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate,
fragrance, sodium citrate, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydroxypropyl methylcellulose, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

NEW

head &
shoulders ®

CLINICAL

SOLUTIONS

SELENIUM SULFIDE

DANDRUFF & SEBORRHEIC DERMATITIS SHAMPOO

ITCH SHAMPOO

Up To 7-Day Protection

Itch + Dryness Redness +

CLINICALLY PROVEN

130 mL (4.3 FL OZ

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS ITCH 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-154-13	130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2016	05/24/2021
2	NDC: 69423-154-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2016	05/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/17/2016	05/24/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)