NDC Code(s) : 30142-788-15, 30142-788-32
Packager : The Kroger Co.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clean ApplePyrithione zinc SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-788
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 ZINC10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC CARBONATE(UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE(UNII: G4LZF950UR)
AMODIMETHICONE (800 CST)(UNII: 363Z2T48P7)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)(UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE(UNII: YQO029V1L4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:30142-788-15420 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/06/2013
2NDC:30142-788-32370 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/02/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 12/06/2013

LABELER - The Kroger Co.(006999528)

REGISTRANT - Consumer Product Partners, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091514 manufacture(30142-788)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091520 manufacture(30142-788)

PRINCIPAL DISPLAY PANEL

Compare to Head & Shoulders ® Green Apple 2 in 1 Dandruff Shampoo

*SEE BACK PANEL

Kroger ®

PYRITHIONE ZINC

Dandruff Shampoo

PLUS CONDITIONER

2in1

HELPS PREVENT REOCCURRING FLAKES

GREEN APPLE

everyday cleansing with a clean, apple scent

12.5 FL OZ (370 mL)

mm01