Drug Facts

DANDRUFF SHAMPOO - pyrithione zinc lotion/shampoo
Cardinal Health

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.

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Drug Facts

Active ingredient Purpose

Pyrithione Zinc 1% 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, message onto scalp, rinse, repeat if desired
• for best result use at least twice a week or as directed by doctor

Inactive ingredients water, sodium laureth sulfate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA,
zinc carbonate, behentrimonium chloride, fragrance, magnesium sulfate, sodium benzoate, zinc chloride, sodium citrate, benzyl alcohol, sodium chloride, sodium hydroxide, blue 1, red 4

Compare to
Head + Shoulders
active ingredient
Pyrithione Zinc
Dandruff
Shampoo
Everyday Clean
Everyday basi cleaning
for Normal or Oily Hair
14.2 FL OZ
(420 mL)

DANDRUFF SHAMPOO
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ZINC CARBONATE (UNII: EQR32Y7H0M)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ZINC (UNII: J41CSQ7QDS)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-311-15	.42 L in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358	05/19/1998

Labeler - Cardinal Health (097537435)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture