WECARE ANTI-DANDRUFF- antidandruff shampoo liquid 
Dynarex Corporation

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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1398 Antidandruff Shampoo NDC 67777-139-80

Active ingredient

Pyrithione Zinc 0.5%

Purpose

Anti-Dandruff

Use

Helps eliminate irritation and flaking associated with dandruff

Warnings

For External Use Only

When using this product

  • Avoid contact with eyes
  • If contact occurs, rinse eyes with plenty of water

Stop use and ask a doctor if

condition does not improve or worsens after regular use of this product as directed.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

Acrylates Copolymer, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, CI 42090, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Coco-Glucoside, Dimethiconol, Glyceryl Oleate, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Perfume, Polyquaternium-10, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Styrene/Acrylamide Copolymer, TEA-Dodecylbenzenesulfonate, Water

Label

1398-IN-MASTERDandruff Shampoo

WECARE ANTI-DANDRUFF 
antidandruff shampoo liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC5 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
WATER (UNII: 059QF0KO0R)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO GLUCOSIDE (UNII: ICS790225B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-139-8012 in 1 CASE10/11/2018
1NDC:67777-139-81355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/11/2018
Labeler - Dynarex Corporation (008124539)

Revised: 2/2023
Document Id: f3cd3b53-fbef-5d96-e053-2995a90ab8a6
Set id: 7fad58a3-5537-f87a-e053-2991aa0a7cdb
Version: 6
Effective Time: 20230203
 
Dynarex Corporation