OTC Medication Information: Dandruff

DANDRUFF- pyrithione zinc shampoo
TKC Holdings, Inc

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.

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, L.L.C.

Bridgeton, MO 63044

principal display panel

crawford

Normal to Oily

Shampoo

Clears Hair of Dandruff Flakes

Distributed by:

Olivetter Products, L.L.C.

Bridgeton, MO 63044

4FL OZ (118 mL)

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DANDRUFF
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:90089-153
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 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:90089-153-26 118 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 08/03/2020
Labeler — TKC Holdings, Inc (080613787)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (90089-153)

Revised: 07/2021 TKC Holdings, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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