DRUGS FACTS

ACTIVE INGREDIENTS

Pyrithione zinc 1%

PURPOSE

Anti-dandruff

USES

Help prevent recurrence of flaking and itching associated with dan druff

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 procuct as directed.

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

DIRECTIONS

for best results use at least twice a week or as directed by doctor.
for maximun dandruff control, use every time you shampoo
shake bedore use
wet hair, message onto scalp, rinse, repeat if desired.

WATER, SODIUM LAURYL SULFATE, SODIUM LAURETH SULDATE, GLYCOL DISTEARATE , ZINC CARBONATE, SODIUM CHLORIDE, SODIUM XYLENESULFONATE, COCAMIDOPROPYL BETAINE, FRAGANCE, DIMETHICONE, SODIUM BENZOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1, RED 33

pyrithione zinc HEAD AND SHOULDERS MEN OLD SPICE

HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

HEAD AND SHOULDER MEN OLD SPICE
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69772-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.01 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69772-102-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2015
2	NDC:69772-102-02	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2015
3	NDC:69772-102-03	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2015
4	NDC:69772-102-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2015
5	NDC:69772-102-05	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	06/16/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Name	Address	ID/FEI	Business Operations
Establishment
Teresa Cecena DBA Genesis		078760958	relabel(69772-102)

Name	Address	ID/FEI	Business Operations
Establishment
Procter and Gamble Manufacturara SA De CV		812807550	manufacture(69772-102)