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Assured by Greenbrier International Inc.

Medically reviewed on January 20, 2017

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1g in 100mL
Labeler: Greenbrier International Inc.
NDC Code: 33992-0700

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.

Assured Dandruff Shampoo

Drug Facts

Active Ingredient

Zinc Pyrithione 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.
  • wet hair.
  • massage into scalp.
  • rinse.
  • repeat if desired.
  • for best results, use at least twice a week or as directed by a doctor.
  • for maximum dandruff control, use every time you shampoo.

Other information

  • store at 20°C (69° to 77°F)

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Glycol Distearate, Sodium Chloride, Fragrance, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN CANADA

ASSURED™

Dandruff Shampoo

Dry Scalp Care

MOISTURIZING

RELIEVES

DRYNESS • ITCHING • FLAKING

13.5 FL OZ (400 mL)

ASSURED 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0700
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 
COCAMIDOPROPYL BETAINE 
SODIUM LAUROAMPHOACETATE 
GLYCOL DISTEARATE 
SODIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
DISODIUM ETHYLENEDIAMINEDIACETATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:33992-0700-1400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/19/2017
Labeler - Greenbrier International Inc. (610322518)
Registrant - Willard Manufacturing Inc. (208799143)
Establishment
NameAddressID/FEIOperations
Willard Manufacturing Inc.208799143manufacture(33992-0700)

 
Greenbrier International Inc.

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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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