HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE ITCH RELIEF- selenium sulfide lotion/shampoo

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

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Active ingredient:
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)
Available from:
The Procter & Gamble Manufacturing Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-dandruff, anti-seborrheic dermatitis helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.
Authorization status:
OTC monograph final
Authorization number:
69423-527-40

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HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE

ITCH RELIEF- selenium sulfide 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

2in1 Clinical Strength Dandruff Defense Intensive Itch Relief

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpos e

Anti-dandruff, anti-seborrheic dermatitis

Us es

helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and

seborrheic dermatitis.

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

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.

caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.

Inactive ingredients

Water, ammonium laureth sulfate, ammonium lauryl sulfate,glycol distearate, cocamide MEA, ammonium

xylenesulfonate, sodium citrate, dimethicone, menthol, cetyl alcohol, fragrance, citric acid, sodium

chloride, sodium benzoate, disodium EDTA, stearyl alcohol, hydroxypropyl methylcellulose, mentha

piperita (peppermint) oil, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone,

®

red 4.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

head &

shoulders ®

selenium sulfide dandruff &

seborrheic dermatitis shampoo

2in1

Clinical Strength

Dandruff Defense

ntensive

Itch Relief

Extra strength formula

with Intense Cooling Menthol

I13.5 FL OZ (400 mL)

HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE

INTENSIVE ITCH RELIEF

selenium sulfide lotion/shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 423-527

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SELENIUM SULFIDE (UNII: Z6 9 D9 E38 1Q) (SELENIUM SULFIDE - UNII:Z6 9 D9 E38 1Q)

SELENIUM SULFIDE

1 g in 10 0 mL

The Procter & Gamble Manufacturing Company

Inactive Ingredients

Ingredient Name

Stre ng th

MENTHA ARVENSIS LEAF O IL (UNII: 1AEY1M553N)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

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

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

WATER (UNII: 0 59 QF0 KO0 R)

AMMO NIUM LAURYL SULFATE (UNII: Q7AO2R1M0 B)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

AMMO NIUM XYLENESULFO NATE (UNII: 4FZY6 L6 XCM)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C RED NO . 4 (UNII: X3W0 AM1JLX)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

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

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 423-527-

40 0 mL in 1 BOTTLE, PLASTIC; 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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