Pyrithione Zinc Shampoo
FDA Label NDC 75712-470

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Pyrithione Zinc (NDC 75712-470). 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 controll, 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, Mentha piperita (peppermint) oil, Mentha arvensis leaf oil, Melaleuca alternifolia (tea tree) leaf oil, citric acid, methylchloroisothiazolinone, methylisothiazolinone, hydroxycitronellal, linalool, blue 1, yellow 5

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders® Tea Tree Oil 2in1 Dandruff Shampoo + Conditioner.

Adverse Reactions

100% Satisfaction

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DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal Display Panel

STUDIO

SELECTION

TEA TREE

DANDRUFF SHAMPOO + CONDITIONER

PYRITHIONE ZINC 1%

Compare to Head & Shoulders® Tea Tree Oil 2 in 1 Dandruff Shampoo & Conditioner*

Cooling relief from scalp itch

Paraben free

2in1

Paraben + Phthalate Free

12.5 FL OZ (370 mL)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.