PERSONAL CARE PYRITHIONE ZINC DANDRUFF - pyrithione zinc shampoo 
Personal Care 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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Personal Care Pyrithione Zinc Dandruff Shampoo - Dry Scalp Care

Drug Facts
Active ingredient

Pyrithione Zinc 1%                          

Purpose

Anti-dandruff

Use

 helps prevent recurrence of flaking and itching associated with dandruff.

Warning

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

Inactive Ingredients

water (aqua), sodium laureth sulfate,  sodium lauryl sulfate, cocamide MEA, sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betain, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone,  methylisothiazolinone, FD and C Blue 1

Personal Care Dry Scalp Dandruff Shampoo

Personal  Care

eucalyptus

DRY SCALP

Pyrithione Zinc

Dandruff

Shampoo

helps relieve itching & flaking while moisturizing to help

PREVENT DRYNESS

13.5 FL OZ (400 mL)

Distributed by:

Personal Care Products, LLC

Troy, Michigan 48084

U.S.A.

Made in China

PC Dandruff Dry 2216

PERSONAL CARE PYRITHIONE ZINC DANDRUFF  
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2216
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 4.04 g  in 400 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29500-2216-0 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 01/07/2011
Labeler - Personal Care Products, LLC (966155082)
Registrant - Personal Care Products, LLC (966155082)
Establishment
Name Address ID/FEI Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd 530766098 manufacture(29500-2216)

Revised: 6/2016
Document Id: f95c434f-e25d-4cfa-bd7c-ca788e4b458a
Set id: 155b8a12-a17d-42ba-9394-12518f7a94dc
Version: 4
Effective Time: 20160629
 
Personal Care Products, LLC