NDC Code(s) : 69423-159-38
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 Instant Hydration Pyrithione Zinc LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69423-159
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 ZINC0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ORCHIS MASCULA FLOWER(UNII: 6H1JQK35LA)
COCONUT(UNII: 3RT3536DHY)
CORN SILK(UNII: 7D3VB244UX)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE(UNII: K7VEI00UFR)
GLUTAMIC ACID(UNII: 3KX376GY7L)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALMOND OIL(UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69423-159-3850 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 11/10/2016 12/28/2018

PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff conditioner

INSTANT hydration
HAIR & SCALP
CONDITIONER

feel it restore hair & scalp moisture

12.8 FL OZ
(380 mL) HS1