NDC Code(s) : 37000-347-38, 37000-347-66
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:37000-347
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
CORN SILK(UNII: 7D3VB244UX)
ORCHIS MASCULA FLOWER(UNII: 6H1JQK35LA)
WATER(UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIMETHICONE(UNII: 92RU3N3Y1O)
COCO MONOETHANOLAMIDE(UNII: C80684146D)
ZINC CARBONATE(UNII: EQR32Y7H0M)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE(UNII: G4LZF950UR)
CETYL ALCOHOL(UNII: 936JST6JCN)
MAGNESIUM SULFATE, UNSPECIFIED(UNII: DE08037SAB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE(UNII: YQO029V1L4)
BENZYL ALCOHOL(UNII: LKG8494WBH)
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)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)(UNII: B16G315W7A)
COCONUT(UNII: 3RT3536DHY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-347-38380 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2014
2NDC:37000-347-66665 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 11/07/2018

PRINCIPAL DISPLAY PANEL

3 Action

FORMULA

head &
shoulders ®

pyrithione zinc dandruff shampoo

INSTANT
hydration

feel it restore hair & scalp moisture

FLAKE FREE.*

UP TO 100%

GUARANTEED^

12.8 FL OZ
(380 mL)

HS1