Head and Shoulders ® Clinical Solutions Dandruff

Head and Shoulders Repair and Protect by

Drug Labeling and Warnings

Head and Shoulders Repair and Protect by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEAD AND SHOULDERS REPAIR AND PROTECT- pyrithione zinc 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.

----------

Head and Shoulders ® Clinical Solutions Dandruff

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff,Anti-seborrheic dermatitis

Use

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, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

head &

shoulders ®

CLINICAL SOLUTIONS

SELENIUM SULFIDE

DANDRUFF & SEBORRHEIC DERMATITIS SHAMPOO

DANDRUFF SHAMPOO

Up to 7-Day Protection

Dandruff * Flaking * Seborrheic Dermatitis

CLINICALLY PROVEN

130 mL (4.3 FL OZ)

HEAD AND SHOULDERS REPAIR AND PROTECT 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-153-13	1 in 1 CARTON	11/17/2016	12/01/2019
1		130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 69423-153-25	1 in 1 CARTON	11/17/2016	12/01/2019
2		250 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	11/17/2016	12/01/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019

Document Id: 8c278b6f-d343-b750-e053-2995a90ad7e9

34390-5

Set id: 4197325c-8026-36d6-e054-00144ff8d46c

Version: 2

Effective Time: 20190625

 

The Pr