Dandruff Lotion/shampoo
FDA Label NDC 53942-311

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Super Markets, Inc for the product Dandruff (NDC 53942-311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding claims, active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Active Ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

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.

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

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

Disclaimer

this product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders Classic clean 2 in 1 pyrithione zinc Dandruff Shampoo & Conditioner.

Adverse Reactions

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

MADE IN USE WITH US AND FOREIGN COMPONENTS

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MORE FOR YOUR DOLLAR

Market Basket

pyrithione zinc

Dandruff

Shampoo

plus conditioner everyday clean

For normal/Oily Hair

Compare to Head & Shoulders Active Ingredient

14.2 FL OZ  (420 mL)

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