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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:69772-139
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.01 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:69772-139-40 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
2 NDC:69772-139-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
3 NDC:69772-139-20 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
4 NDC:69772-139-70 700 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
5 NDC:69772-139-11 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
6 NDC:69772-139-05 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 04/23/2015
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