head and shoulders ®

head and shoulders ®
SPL v5
SPL
SPL Set ID b6ad7707-9d02-31a6-e053-2a95a90ae7ad
Route
topical
Published
Effective Date 2020-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (1 g)
Inactive Ingredients
cocamidopropyl betaine edetate disodium menthol, unspecified form hypromellose, unspecified water sodium lauryl sulfate glycol distearate sodium chloride sodium xylenesulfonate dimethicone sodium benzoate fd&c red no. 4 sodium citrate citric acid monohydrate peppermint oil mentha arvensis leaf oil

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2020-11-17 Until 2026-12-01

Purpose

Anti-dandruff, anti-seborrheic dermatitis

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

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

Purpose

Anti-dandruff, anti-seborrheic dermatitis

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, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3

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

Active Ingredient

Selenium Sulfide 1%

Questions (or Comments)?

1-800-723-9569

Stop Use and Ask A Doctor If

condition worsens or does not improve after regular use of this product as directed

Principal Display Panel Bottle Label

head &

shoulders ®



selenium sulfide dandruff &

seborrheic dermatitis shampoo

Clinical Strength

Dandruff Defense

Intensive

Itch Relief

13.5 FL OZ (400 mL)


Structured Label Content

Warnings

For external use only.

Uses

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

Purpose

Anti-dandruff, anti-seborrheic dermatitis

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 (Inactive ingredients)

Water, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

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

Active Ingredient (Active ingredient)

Selenium Sulfide 1%

Questions (or Comments)? (Questions (or comments)?)

1-800-723-9569

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve after regular use of this product as directed

Principal Display Panel Bottle Label (PRINCIPAL DISPLAY PANEL - BOTTLE LABEL)

head &

shoulders ®



selenium sulfide dandruff &

seborrheic dermatitis shampoo

Clinical Strength

Dandruff Defense

Intensive

Itch Relief

13.5 FL OZ (400 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)