HEAD AND SHOULDERS ROYAL OILS MOISTURIZING CO-WASH- pyrithione zinc lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Available from:
The Procter & Gamble Manufacturing Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-dandruff helps prevent recurrence of flaking and itching associated with dandruff.
Authorization status:
OTC monograph final
Authorization number:
69423-306-45

HEAD AND SHOULDERS ROYAL OILS MOISTURIZING CO-WASH- 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.

----------

Head and Shoulders

Royal Oils Moisturing Co-Wash

Drug Facts

Active ingredient

Pyrithione zinc 0.5%

Purpos e

Anti-dandruff

Us es

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.

wet hair,massaging into hair and scalp. Expect low lather. Rinse, repeat if desired

Inactive ingredients

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, cocos nucifera

(coconut) oil, fragrance, glutamic acid, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride,

methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

®

PRINCIPAL DISPLAY PANEL - 450 mL Bottle Label

head &

shoulders

pyrithione zinc dandruff Co-Wash

ROAYL OILS

MOISTURIZING CO-WASH

WITH COCONUT OIL

GENTLY CLEANS AND HYDRATES

LONG-LASTING SCALP RELIEF*

FOR CURLY TO RELAXED HAIR

SULFATE, PARABEN &

DYE FREE, LOW LATHER

15.2 FL OZ

(450 mL)

HEAD AND SHOULDERS ROYAL OILS MOISTURIZING CO-WASH

pyrithione zinc lotion

®

The Procter & Gamble Manufacturing Company

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 423-30 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

PYRITHIONE ZINC

0 .5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLUTAMIC ACID (UNII: 3KX376 GY7L)

STEARAMIDO PRO PYL DIMETHYLAMINE (UNII: K7VEI0 0 UFR)

WATER (UNII: 0 59 QF0 KO0 R)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 423-30 6 -

450 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /30 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 8 /30 /20 18

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2019

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