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DANDRUFF by TOPCO ASSOCIATES LLC

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1g in 100mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-309

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.

DRUG FACTS

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

to help prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

avoid contact with 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 of this product as directed.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions
  • for maximum dandruff control, use every time you shampoo.
  • wet hair, massage onto scalp and rinse.
  • repeat if desired.

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Zinc Carbonate, Sodium Xylenesulfonate, Cocamidopropyl Betaine, Dimethicone, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Magnesium Sulfate, Benzyl Alcohol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM CHLORIDE 
GLYCOL DISTEARATE 
ZINC CARBONATE 
SODIUM XYLENESULFONATE 
COCAMIDOPROPYL BETAINE 
DIMETHICONE 
SODIUM BENZOATE 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
MAGNESIUM CARBONATE HYDROXIDE 
MAGNESIUM SULFATE, UNSPECIFIED 
BENZYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:36800-309-13420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/19/2017
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE INC. (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE INC.201901209manufacture(36800-309)

Revised: 06/2017
 
TOPCO ASSOCIATES LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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