Simply U 153.008/153bd

Drug Facts

Composition & Product

Active Ingredients

Pyrithione Zinc (10 mg)

Inactive Ingredients

Water Sodium Chloride Zinc Carbonate Methylisothiazolinone Fd&c Blue No. 1 Sodium Xylenesulfonate Sodium Laureth Sulfate Glycol Distearate Sodium Lauryl Sulfate D&c Red No. 33 Cocamidopropyl Betaine Methylchloroisothiazolinone Citric Acid Monohydrate Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Amodimethicone (800 Cst) Sodium Benzoate Magnesium Carbonate Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-14

Medication Information

Purpose

Anti-dandruff

Description

Multiple benefit formula to help: Fight dry scalp Reduce oiliness Calm itch Prevent flakes Relieve irritation Leave hair healthy looking Soothe and reduce redness

Use

helps prevent recurrence of flaking and itching associated with dandruff

Claims

Multiple benefit formula to help:

Fight dry scalp
Reduce oiliness
Calm itch
Prevent flakes
Relieve irritation
Leave hair healthy looking
Soothe and reduce redness

Warnings

For external use only

Directions

shake well
for maximum dandruff control, use every time you shampoo
wet hair, massage onto scalp, rinse, repeat if desired
for best results use at least twice a week or as directed by a doctor

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ^® Classic Clean Dandruff Shampoo.

Adverse Reaction

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient

Pyrithione zinc 1%

Inactive Ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Principal Display Panel

SIMPLY U ^®

DANDRUFF

SHAMPOO

PYRITHIONE ZINC

EVERYDAY CLEAN

Helps relieve scalp dryness, itch and irritaion
Gentle and pH balanced for everyday use

Compare to Head & Shoulders ^® Classic Clean Dandruff Shampoo*

12.5 FL OZ (370 mL)

When Using This Product

do not get into 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 as directed

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

helps prevent recurrence of flaking and itching associated with dandruff

Claims

Multiple benefit formula to help:

Fight dry scalp
Reduce oiliness
Calm itch
Prevent flakes
Relieve irritation
Leave hair healthy looking
Soothe and reduce redness

Purpose

Anti-dandruff

Warnings

For external use only

Directions

shake well
for maximum dandruff control, use every time you shampoo
wet hair, massage onto scalp, rinse, repeat if desired
for best results use at least twice a week or as directed by a doctor

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ^® Classic Clean Dandruff Shampoo.

Adverse Reaction

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Inactive Ingredients (Inactive ingredients)

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Principal Display Panel (Principal display panel)

SIMPLY U ^®

DANDRUFF

SHAMPOO

PYRITHIONE ZINC

EVERYDAY CLEAN

Helps relieve scalp dryness, itch and irritaion
Gentle and pH balanced for everyday use

Compare to Head & Shoulders ^® Classic Clean Dandruff Shampoo*

12.5 FL OZ (370 mL)

When Using This Product (When using this product)

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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

condition worsens or does not improve after regular use as directed

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "helps prevent recurrence of flaking and itching associated with dandruff", "Claims": "Multiple benefit formula to help: Fight dry scalp Reduce oiliness Calm itch Prevent flakes Relieve irritation Leave hair healthy looking Soothe and reduce redness", "Purpose": "Anti-dandruff", "Warnings": "For external use only", "Directions": "shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor", "Disclaimer": "*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Classic Clean Dandruff Shampoo.", "Adverse Reaction": "Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593", "Active ingredient": "Pyrithione zinc 1%", "Inactive ingredients": "water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33", "Principal display panel": "SIMPLY U ® DANDRUFF SHAMPOO PYRITHIONE ZINC EVERYDAY CLEAN Helps relieve scalp dryness, itch and irritaion Gentle and pH balanced for everyday use Compare to Head & Shoulders ® Classic Clean Dandruff Shampoo* 12.5 FL OZ (370 mL)", "When using this product": "do not get into 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 as directed", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information