BEING WELL BODY DRY SCALP CARE- 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 acrylates copolymer, benzyl alcohol, cetyl alcohol, citric acid, cocamide MEA, dimethicone, fragrance, glycol distearate, guar hydroxypropyltrimonium chloride, methylchloroisothiazolinone, methylisothiazolinone, prunus amygdalus dulcis (sweet almond) oil, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine, water, zinc sulfate 

image description

BEING WELL BODY  DRY SCALP CARE
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-511
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ALMOND OIL (UNII: 66YXD4DKO9)  
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:46994-511-23 700 mL in 1 BOTTLE, PLASTIC
2 NDC:46994-511-14 420 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: 7e2ed247-5bec-4fce-9464-2926aaad6f81
Set id: 9f8f976b-9e5e-4f18-baac-a1f0adaa7738
Version: 1
Effective Time: 20130320
 
Save-A-Lot Food Stores Ltd