Care One 281.007/281ak,an

Care One 281.007/281ak,an
SPL v5
SPL
SPL Set ID 592ec7c5-44b8-405b-88a2-f02aa6c620f0
Route
TOPICAL
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Sodium Lauryl Sulfate Sodium Laureth Sulfate Glycol Distearate Sodium Chloride Water Zinc Carbonate Sodium Xylenesulfonate Amodimethicone (800 Cst) Cocamidopropyl Betaine Sodium Benzoate Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Magnesium Carbonate Hydroxide Citric Acid Monohydrate Almond Oil Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-11-02 Until 2026-01-17

Description

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ®  Dry Scalp Care Dandruff Shampoo.

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ®  Dry Scalp Care Dandruff Shampoo.

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

Directions
  • shake well
  • for maximum dandruff control, use everytime 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 ® Dry Scalp Care Dandruff Shampoo.

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

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, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Principal Display Panel

CAREone ®

Compare to Head & Shoulders ®Dry Scalp Care Dandruff Shampoo*

DRY SCALP DANDRUFF SHAMPOO

With Added Almond Oil

  • Dandruff Fighting Formula
  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

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

Purpose

Anti-dandruff

Warnings

For external use only

Directions
  • shake well
  • for maximum dandruff control, use everytime 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 ® Dry Scalp Care Dandruff Shampoo.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

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, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Principal Display Panel

CAREone ®

Compare to Head & Shoulders ®Dry Scalp Care Dandruff Shampoo*

DRY SCALP DANDRUFF SHAMPOO

With Added Almond Oil

  • Dandruff Fighting Formula
  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

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


Raw Label Data

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