HEAD AND SHOULDERS- pyrithione zinc lotion/shampoo 
Teresa Cecena DBA Genesis

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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WARNININGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

Stop use and ask a doctor if

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

DIRECTIONS

PYRITHIONE ZINC 1%

Water,sodium laureth sulfate, sodium lauryl sulfate, cocamide mea, zinc carbonate, glycol distearate, dimethicone, fragance, guarhydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone,methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

PURPOSE

Anti-drandruff

FOR EXTERNAL USE ONLY

FOR BEST RESULTS USE A LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

HEAD AND SHOULDER

HEAD AND SHOULDERS 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
C.I. ACID BLUE 324 (UNII: QCA734O5N6)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-139-40400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
2NDC:69772-139-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
3NDC:69772-139-20200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
4NDC:69772-139-70700 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
5NDC:69772-139-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
6NDC:69772-139-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/23/2015
Labeler - Teresa Cecena DBA Genesis (078760958)

Revised: 4/2017
Document Id: 4d785380-befc-6f54-e054-00144ff8d46c
Set id: 1469154b-47d8-00a9-e054-00144ff88e88
Version: 2
Effective Time: 20170418
 
Teresa Cecena DBA Genesis