HEAD AND SHOULDERS APPLE CIDER VINEGAR- pyrithione zinc lotion/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:
69423-521-01, 69423-521-40, 69423-521-95

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HEAD AND SHOULDERS APPLE CIDER VINEGAR- pyrithione zinc lotion/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

Apple Cider Vinegar 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, sodiumlaureth sulfate, cocamideMEA, sodium xylenesulfonate, zinc carbonate, glycol distearate,

sodiumlauryl sulfate, sodium chloride, cocamidopropyl betaine, vinegar, fragrance, guar

hydroxypropyltrimoniumchloride, sodiumbenzoate, dimethicone, stearyl alcohol,magnesium carbonate

hydroxide, cetyl alcohol, polyquaternium-76, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

®

1-800-723-9569

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

Paraben Free

head &

shoulders ®

pyrithione zinc dandruff shampoo

Apple Cider Vinegar

Shampoo

Clarifies Scalp & Restores Shine to Hair

Infused with Apple Cider Vinegar

FLAKE FREE.*

UP TO 100%

GUARANTEED^

13.5 FL OZ (400 mL)

HEAD AND SHOULDERS APPLE CIDER VINEGAR

pyrithione zinc lotion/shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 423-521

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

The Procter & Gamble Manufacturing Company

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 )

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

ZINC CARBO NATE (UNII: EQR32Y7H0 M)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

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

ACETIC ACID (UNII: Q40 Q9 N0 6 3P)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 423-521-

40 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/17/20 20

2

NDC:6 9 423-521-

2 in 1 CELLO PACK

11/17/20 20

2

9 50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:6 9 423-521-

9 50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

11/17/20 20

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

11/17/20 20

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2020

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