HEAD AND SHOULDERS BREAKEGE PREVENTION- pyrithione zinc 1% lotion/shampoo

HEAD AND SHOULDERS by

Drug Labeling and Warnings

HEAD AND SHOULDERS by is a Otc medication manufactured, distributed, or labeled by TERESA CECENA DBA GENESIS, Teresa Cecena, PROCTER AND GAMBLE MANUFACTURA S. DE R.L. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENT

PHYRITHIONE ZINC 1%

PURPOSE

PURPOSE

Anti-drandruff

USER SAFETY WARNINGS

USES

Helps prevent recurrence of flaking and itching associated with drandruff

Help prevent hair loss

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

• avoid contact with eyes If contact occurs, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR IF

• condition worsens or does not improve 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.

DOSAGE & ADMINISTRATION

DIRECTIONS

• for maximun drandruff control, use every time you shampoo
• wet hair, message onto scalp, rinse, repeat if desired
• For best results use al least twice a week or as directed by a doctor.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

DIRECTIONS

• FOR MAXIMUN DRANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO
• WET HAIR, MESSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED
• FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  BREAKEGE PREVENTION
pyrithione zinc 1% lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-141
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-141-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2015
2	NDC: 69772-141-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2015
3	NDC: 69772-141-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2015
4	NDC: 69772-141-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2015
5	NDC: 69772-141-18	1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/12/2015

Labeler - TERESA CECENA DBA GENESIS (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
PROCTER AND GAMBLE MANUFACTURA S. DE R.L. DE C.V.		812807550	manufacture(69772-141)