HEAD AND SHOULDERS- pyrithione zinc lotion/shampoo

HEAD AND SHOULDERS by

Drug Labeling and Warnings

HEAD AND SHOULDERS by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

WARNININGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

INDICATIONS & USAGE

DIRECTIONS

• for maximum dandruff control, use every time you shampoo.
• wet hair, message onto scalp, rinse, repeat if desired.
• for best results use at least twice a week or as directed by a doctor.

ACTIVE INGREDIENT

PYRITHIONE ZINC 1%

INACTIVE INGREDIENT

Water,sodium laureth sulfate, sodium lauryl sulfate, cocamide mea, zinc carbonate, glycol distearate, dimethicone, fragance, guarhydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone,methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

PURPOSE

PURPOSE

Anti-drandruff

DOSAGE & ADMINISTRATION

FOR EXTERNAL USE ONLY

FOR BEST RESULTS USE A LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS 
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC CARBONATE (UNII: EQR32Y7H0M)
C.I. ACID BLUE 324 (UNII: QCA734O5N6)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-139-40	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015
2	NDC: 69772-139-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015
3	NDC: 69772-139-20	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015
4	NDC: 69772-139-70	700 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015
5	NDC: 69772-139-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015
6	NDC: 69772-139-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/23/2015

Labeler - Teresa Cecena DBA Genesis (078760958)