PERSONAL CARE DRY SCALP- pyrithione zinc shampoo 
Delta Brands & Products LLC

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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DRUG FACTS

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps to treat flakes, itch, irritation, oilness or dryness caused by 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

■ if condition does not improve or worsen 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

■ wet hair ■ squeeze small amount into palm ■ lather ■ rinse well ■ for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water (aqua), sodium laureth sulfate sodium lauryl sulfate, cocamide MEA,sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betaine, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone,FD&C Blue No. 1

Package Label

Package Label

PERSONAL CARE  DRY SCALP
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-047
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
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-047-13400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/09/2018
Labeler - Delta Brands & Products LLC (080999173)

Revised: 4/2018
Document Id: 69ac5657-d5a3-1abc-e053-2991aa0a26d7
Set id: 69ac5232-e93e-2277-e053-2991aa0a28c6
Version: 1
Effective Time: 20180412
 
Delta Brands & Products LLC