BEING WELL BODY 2IN1 DANDRUFF AND CONDITIONER- pyrithione zinc shampoo 
Save-A-Lot Food Stores Ltd

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 

Uses • 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 worsen after regular use of this product as directed

Keep this and all drugs out of reach of children If swallowed get medical help or contact a Poison Control Center right away.

Directions •wet hair •lather •massage onto scalp •rinse well •repeat if desired •for best results use regularly

Inactive Ingredients 

Inactive ingredientsacrylates copolymer, benzyl alcohol, cetyl alcohol, cocamide MEA, dimethicone, FDC blue no.1, fragrance, glycol distearate, methylchloroisothiazolinone, methylisothiazolinone, polyquaterinum-10, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine, water, zinc sulfate

image description

BEING WELL BODY  2IN1 DANDRUFF AND CONDITIONER
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-510
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ZINC SULFATE (UNII: 89DS0H96TB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46994-510-23 700 mL in 1 BOTTLE, PLASTIC
2 NDC:46994-510-14 420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 03/25/2013
Labeler - Save-A-Lot Food Stores Ltd (095484572)

Revised: 3/2013
Document Id: 5ac4701d-89dd-4bc8-85a8-66d66ed8b146
Set id: 0fe3ea18-845a-4847-90e7-0e918a85307b
Version: 1
Effective Time: 20130320
 
Save-A-Lot Food Stores Ltd