Pyrithione Zinc Shampoo
FDA Label NDC 11344-131

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Pyrithione Zinc (NDC 11344-131). 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

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Disclaimer

→ Adverse Reaction

→ Principal Display Panel

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, distributor of Head & Shoulders ^® Classic Clean 2in1 Dandruff Shampoo + Conditioner.