NDC Code(s) : 21130-153-15, 21130-153-40, 21130-153-35
Packager : Better Living Brands LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DandruffPyrithione zinc SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-153
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)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:21130-153-15420 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/08/1998
2NDC:21130-153-40612 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/11/2023
3NDC:21130-153-35700 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/08/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 12/08/1998

LABELER - Better Living Brands LLC(009137209)

REGISTRANT - Consumer Product Partners, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091520 manufacture(21130-153)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091514 manufacture(21130-153)

PRINCIPAL DISPLAY PANEL

Signature Care™

Dandruff Shampoo

For Normal or Oily Hair

Compare to Head & Shoulders Classic Clean Dandruff Shamppo*

Pyrithione zinc 1%

Quality Guaranteed

20.7 FL OZ (1.29 PT) 612 mL

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PRINCIPAL DISPLAY PANEL

COMPARE TO Head & Shoulders ® Classic Clean

Signature SELECT ®

Dandruff SHAMPOO

PYRITHIONE ZINC 1%

FOR NORMAL OR OILY HAIR

GENTLE FOR EVERYDAY USE HELPS PREVENT FLAKES

20.7 FL OZ (1.29 PT) 612 mL

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