NDC Code(s) : 37000-343-01, 37000-343-50, 37000-343-12, 37000-343-38
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 Conditioner Pyrithione Zinc LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-343
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
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE(UNII: K7VEI00UFR)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLUTAMIC ACID(UNII: 3KX376GY7L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PEPPERMINT OIL(UNII: AV092KU4JH)
MENTHOL(UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL(UNII: 1AEY1M553N)
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:37000-343-0110 mL in 1 POUCH Type 0: Not a Combination Product09/01/2014
2NDC:37000-343-5050 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2014
3NDC:37000-343-12125 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2014
4NDC:37000-343-38380 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 09/01/2014 08/17/2018

PRINCIPAL DISPLAY PANEL

COOLS
ON CONTACT

head &
shoulders ®

pyrithione zinc dandruff conditioner

INSTANT
relief

CONDITIONER

feel the cooling relief instantly

with peppermint complex
and tea tree essence

12.8 FL OZ
(380 mL)

96857022

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label