Head and Shoulders ® Clinical Solutions Leave-On Dandruff Treatment

Head and Shoulders Clinical Solutions Leave-On Dandruff Treatment by

Drug Labeling and Warnings

Head and Shoulders Clinical Solutions Leave-On Dandruff Treatment 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 CLINICAL SOLUTIONS LEAVE-ON DANDRUFF TREATMENT- pyrithione zinc liquid 
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.

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Head and Shoulders ®
Clinical Solutions Leave-On Dandruff Treatment

Drug Facts

Active ingredient

Pyrithione zinc 0.1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

FLAMMABLE. DO NOT USE NEAR FLAME OR WHILE SMOKING. USE ONLY IN
VENTILATED AREAS.

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

entire scalp.

• apply to affected areas one to four times daily or as directed by a doctor.
• place package tip close to scalp on damp or dry hair and use 15 sprays to cover the

Inactive ingredients

Alcohol denat., water/eau, niacinamide, caffeine, BIS-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, fragrance/parfum, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label

head &

shoulders ®

CLINICAL

SOLUTIONS

pyrithione zinc

dandruff treatment

LEAVE-ON DANDRUFF TREATMENT

24hr Protection

Dandruff * Itch * Irritation

CLINICALLY PROVEN

125 mL (4.2 FL OZ)

HEAD AND SHOULDERS CLINICAL SOLUTIONS LEAVE-ON DANDRUFF TREATMENT 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
CAFFEINE (UNII: 3G6A5W338E)
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)
PANTHENOL (UNII: WV9CM0O67Z)
EDETOL (UNII: Q4R969U9FR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-152-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/17/2016	01/15/2019
2	NDC: 69423-152-12	125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/17/2016	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/17/2016	02/01/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2020

Document Id: 9d26d69a-6e9a-148b-e053-2a95a90aca84

34390-5

Set id: 41963d1c-8dda-08ef-e054-00144ff8d46c

Version: 3

Effective Time: 20200127

 

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