DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by TKC Holdings, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acitive 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

Adverse reactions

Distributed by:

Olivette Products

Bridgeton, MO 63044

principal display panel

crawford

Dandruff

Shampoo

Helps Clear Hair of Dandruff Flakes

Distributed by:

Olivette Products

Bridgeton, MO 63044

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90089-153
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90089-153-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	08/03/2020

Labeler - TKC Holdings, Inc. (080613787)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091520	manufacture(90089-153)