HEAD AND SHOULDERS CLINICAL STRENGTH- selenium sulfide lotion/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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

helps prevent recurrence of flaking, itching, irritation, scaling and redness 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.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.
• 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, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, sisodiumEDTA, sodium laureth sulfate, hydroxypropyl methylcellulose, camphor, eucalyptol, methylchloroisothiazolinone, methylisothiazolinone, red 4.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

www.headandshoulders.com

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

head &

shoulders ®

selenium sulfide dandruff
and seborrheic dermatitis shampoo

clinical strength

clinically proven relief for severe dandruff

13.5 FL OZ (400 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  CLINICAL STRENGTH
selenium sulfide lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-330
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
EUCALYPTOL (UNII: RV6J6604TK)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-330-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010
2	NDC: 37000-330-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2017
3	NDC: 37000-330-01	2 in 1 CELLO PACK	11/09/2018
3		400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2010

Labeler - The Procter & Gamble Manufacturing Company (004238200)