ASSURED- pyrithione zinc shampoo 
Greenbrier International 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.

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Assured Dandruff Shampoo

Drug Facts

Active Ingredient

Zinc Pyrithione 1%

Purpose

Anti-dandruff

Use

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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 Dandruff Shampoo

ASSURED 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0700-1400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/19/2017
Labeler - Greenbrier International Inc. (610322518)

Revised: 8/2021
Document Id: ca3f225b-72e0-d0d8-e053-2995a90a50c0
Set id: 4688a1ed-9cd4-37a1-e054-00144ff8d46c
Version: 3
Effective Time: 20210823
 
Greenbrier International Inc.