Care One 153.008/153az Rev 1, Ba, Bc, Bd

Care One 153.008/153az Rev 1, Ba, Bc, Bd
SPL v19
SPL
SPL Set ID 8fb44204-b763-4aa5-a6db-94d1b4d98b65
Route
TOPICAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Cocamidopropyl Betaine Sodium Benzoate Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Water Sodium Lauryl Sulfate Sodium Laureth Sulfate Glycol Distearate Sodium Chloride Zinc Carbonate Sodium Xylenesulfonate Amodimethicone (800 Cst) Magnesium Carbonate Hydroxide Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1995-02-15 Until 2023-12-15
Description

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

Purpose

Anti-dandruff

Adverse Reactions

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.

Medication Information

Purpose

Anti-dandruff

Adverse Reactions

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.

Description

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

Use

Helps prevent recurrence or flaking and itching associated with dandruff

Claims

Multiple benefit formula to help:

  • Fight dry scalp
  • Calm Itch
  • Relieve irritation
  • Soothe and reduce redness
  • Reduce oiliness
  • Prevent flakes
  • Leave hair healthy looking
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, the owner of the registered trademark Head & Shoulders Classic Clean Dandruff Shampoo.

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

When Using This Product
  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel

NDC 71476-153-42

CAREone ®

Compare to Head & Shoulders ®Classic Clean Dandruff Shampoo*

EVERYDAY CLEAN

DANDRUFF

SHAMPOO

Dandruff Fighting Formula

  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

28.2 FL OZ (1.76 PT) 834 mL

Stop Use and Ask A Doctor If
  • condition worsens or does not improve after regular use as directed
Keep Out of Each of Children.

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

Structured Label Content

Use

Helps prevent recurrence or flaking and itching associated with dandruff

Claims

Multiple benefit formula to help:

  • Fight dry scalp
  • Calm Itch
  • Relieve irritation
  • Soothe and reduce redness
  • Reduce oiliness
  • Prevent flakes
  • Leave hair healthy looking
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, the owner of the registered trademark Head & Shoulders Classic Clean Dandruff Shampoo.

Active Ingredient (Active ingredient)

Pyrithione zinc 1%

Adverse Reactions (Adverse reactions)

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.

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

When Using This Product (When using this product)
  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel (principal display panel)

NDC 71476-153-42

CAREone ®

Compare to Head & Shoulders ®Classic Clean Dandruff Shampoo*

EVERYDAY CLEAN

DANDRUFF

SHAMPOO

Dandruff Fighting Formula

  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

28.2 FL OZ (1.76 PT) 834 mL

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 Each of Children. (Keep out of each of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:34.552793 · Updated: 2026-03-14T23:12:50.471535