HEAD AND SHOULDERS SUPREME COLOR PROTECT- pyrithione zinc shampoo

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:
69423-346-35

HEAD AND SHOULDERS SUPREME COLOR 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.

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Head and Shoulders

Supreme Color Protect Shampoo

Drug Facts

Active ingredient

Pyrithione zinc 1%

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.

for maximum dandruff control, use every time you shampoo.

shake before use.

wet hair, massage onto scalp, rinse, repeat if desired.

Inactive Ingredients

Water, sodium laureth sulfate, zinc carbonate, glycol distearate, cocamide MEA, cocamidopropyl

betaine, sodium xylenesulfonate, sodium chloride, dimethicone, argania spinosa kernel oil, honey

extract, fragrance, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl

alcohol, magnesium carbonate hydroxide, cetyl alcohol, methylchloroisothiazolinone,

methylisothiazolinone

Questions (or comments)?

1-800-723-9569

®

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 350 mL Bottle Label

head &

shoulders

PYRITHIONE ZINC DANDRUFF

SCALP & HAIR SHAMPOO

SUPREME

COLOR

PROTECT

WITH ARGAN OIL

& MANUKA HONEY

FREE FROM

PHOSPHATES

PARABENS

PHTHALATES

DYES

11.8 FL OZ

(350 mL)

®

HEAD AND SHOULDERS SUPREME COLOR PROTECT

pyrithione zinc shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 423-346

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

1 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

WATER (UNII: 0 59 QF0 KO0 R)

The Procter & Gamble Manufacturing Company

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

ZINC CARBO NATE (UNII: EQR32Y7H0 M)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

HO NEY (UNII: Y9 H1V576 FH)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ARGAN O IL (UNII: 4V59 G5UW9 X)

PO LYQ UATERNIUM-10 ( 3 0 0 0 0 MPA.S AT 2 %) (UNII: C7RDC8 Y4JS)

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

MAGNESIUM CARBO NATE HYDRO XIDE (UNII: YQO0 29 V1L4)

GUAR HYDRO XYPRO PYLTRIMO NIUM CHLO RIDE ( 1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16 G315W7A)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 423-346 -

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

Pro duc t

0 5/0 2/20 19

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 5/0 2/20 19

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2019

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