Dandruff: Package Insert and Label Information

DANDRUFF- pyrithione zinc shampoo
DOLGENCORP, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching assocaited 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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

This product is not manufactured or distributed by Procter & Gmble, distributor of Head & Shoulders Old Spice Man 2 in 1 Dandruff Shampoo & Conditioner.

100%

Satisfaction

Guaranteed!

(888)309-9030

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

STUDIO

SELECTION for MEN

2 in 1

Dandruff Shampoo

& Conditioner

PYRITHIONE ZINC 1%

Compare to Head & Shoulders

Old Spice Men 2 in 1 Dandruff

Shampoo & Conditioner

Battles dandruff

with a refreshing masculine scent

SMOOTH SPICE

14.2 FL OZ (420 mL)

DANDRUFF pyrithione zinc shampoo

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-128 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength water SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE GLYCOL DISTEARATE SODIUM CHLORIDE ZINC CARBONATE SODIUM XYLENESULFONATE AMODIMETHICONE (800 CST) COCAMIDOPROPYL BETAINE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-128-15 420 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/21/2016

Labeler — DOLGENCORP, LLC (068331990)

Registrant — Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, Inc		088520668	manufacture (55910-128)

Revised: 01/2020 DOLGENCORP, LLC