Pyrithione Zinc by Nice-Pak Products, LLC PYRITHIONE ZINC shampoo

Pyrithione Zinc by

Drug Labeling and Warnings

Pyrithione Zinc by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Adverse Reaction

Distributed by: Nice-Pak Products, LLC

8800 Page Ave

St. Louis, MO 63114

1-888-593-0593

Principal Display Panel

SIMPLY U ®

2-IN-1 DANDRUFF SHAMPOO PLUS CONDITIONER

PYRITHIONE ZINC

EVERYDAY CLEAN

• Helps relieve scalp dryness, itch and irritation
• Gentle and pH balanced for everyday use

Compare to Head & Shoulders ® Classic Clean 2-in-1 Dandruff Shampoo + Conditioner*

12.5 FL OZ (370 mL)

INGREDIENTS AND APPEARANCE

PYRITHIONE ZINC 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ZINC CARBONATE (UNII: EQR32Y7H0M)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-131-32	370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/23/2026

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091520	manufacture(11344-131)