NDC Code(s) : 37000-089-40
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Head and Shoulders Pyrithione Zinc LOTION/SHAMPOO
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-089
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC(UNII: R953O2RHZ5)
(PYRITHIONE ZINC - UNII:R953O2RHZ5) 		PYRITHIONE ZINC1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
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)
LEMON(UNII: 24RS0A988O)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-089-40400 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 09/01/2013 08/10/2018

PRINCIPAL DISPLAY PANEL

#1
DERM
RECOMMENDED

head &
shoulders ®

pyrithione zinc
dandruff shampoo + conditioner

MEN

2in1
DEEP CLEAN

our deepest clean available,
with citrus and mint extracts

FLAKE FREE.*
100%
GUARANTEED^

13.5 FL OZ (400 mL)

96906330

Principal Display Panel - 400 mL Bottle Label