PYRITHIONE ZINC- pyrithione zinc shampoo 
BRANDS INTERNATIONAL

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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Next Gen Dandruff Shampoo

For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.

For best results use at least twice a week or as directed by a doctor.

For external use only.

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.

Helps prevent recurrence of flaking and itching associated with dandruff.

Keep Out of children’s reach.

Anti-dandruff

Pyrithione Zinc 0.3%

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

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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PYRITHIONE ZINC 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
BASIC BLUE 1 (UNII: 92N74OA24D)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-125-10295 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
2NDC:50157-125-35355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03208/16/2022
Labeler - BRANDS INTERNATIONAL (243748238)
Establishment
NameAddressID/FEIBusiness Operations
BRANDS INTERNATIONAL243748238manufacture(50157-125)

Revised: 8/2023
Document Id: 021dabae-fd63-b5a6-e063-6294a90ac2aa
Set id: e65f69d2-233f-9ebf-e053-2995a90a720e
Version: 3
Effective Time: 20230804
 
BRANDS INTERNATIONAL