HEAD AND SHOULDERS BREAKEGE PREVENTION- pyrithione zinc 1% 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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DRUG FACTS

ACTIVE INGREDIENT

PHYRITHIONE ZINC 1%

PURPOSE

Anti-drandruff

USES

Helps prevent recurrence of flaking and itching associated with drandruff

Help prevent hair loss

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

water, sodium laureth sulfate, sodium lauryl sulfate. Coco monoethanolamide, zinc carbonate, glycol distearate, dimethicone, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, benzyl alchohol, tocopheryl acetate, FD&C yellow No5, methylchloroisothiazolinonone, methyllisothiazolinone, FD&C blue No 1

hslp

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

DIRECTIONS

HEAD AND SHOULDERS  BREAKEGE PREVENTION
pyrithione zinc 1% lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-141
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-141-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2015
2NDC:69772-141-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2015
3NDC:69772-141-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2015
4NDC:69772-141-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2015
5NDC:69772-141-181180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/12/2015
Labeler - TERESA CECENA DBA GENESIS (078760958)
Registrant - Teresa Cecena (078760958)
Establishment
NameAddressID/FEIBusiness Operations
PROCTER AND GAMBLE MANUFACTURA S. DE R.L. DE C.V.812807550manufacture(69772-141)

Revised: 5/2015
Document Id: 15e90836-ae24-3979-e054-00144ff88e88
Set id: 15e90836-ae23-3979-e054-00144ff88e88
Version: 1
Effective Time: 20150512
 
TERESA CECENA DBA GENESIS