Head and Shoulders ® Moisture Care Cowash

Drug Labeling and Warnings

Drug Details [pdf]

HEAD AND SHOULDERS MOISTURE CARE COWASH- pyrithione zinc lotion 
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 ®

Moisture Care Cowash

Drug Facts

Active ingredient

Pyrithione zinc 0.5%

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.
• apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredients

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodiumchloride, zea mays (corn) silk extract, prunus amygdalus dulcis (sweet almond) oil, orchis mascula flower extract, cocos nucifera (coconut) fruit extract, methylchloroisothiazolinone, methylisothiazolinone, yellow5, red 33, blue 1.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

For
TEXTURED
Hair

head &
shoulders ®
pyrithione zinc dandruff cowash
CO-WASH

moisture care
with vitamin e rich almond oil
& coconut essence

12.8 FL OZ
(380 mL)

HEAD AND SHOULDERS  MOISTURE CARE COWASH
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-382
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
CORN SILK (UNII: 7D3VB244UX)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
GLUTAMIC ACID (UNII: 3KX376GY7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COCONUT (UNII: 3RT3536DHY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-382-50	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	10/30/2018
2	NDC: 37000-382-12	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	01/01/2017
3	NDC: 37000-382-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	06/18/2019
4	NDC: 37000-382-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016	06/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2014	06/18/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018

Document Id: 6fa19a26-f871-6831-e053-2a91aa0ac4b2

34390-5

Set id: 0f9b493f-4c3b-47b2-9700-f72c9893c041

Version: 4

Effective Time: 20180627

 

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