HEAD AND SHOULDERS BREAKAGE PREVENTION- pyrithione zinc shampoo

Head and Shoulders by

Drug Labeling and Warnings

Head and Shoulders by is a Otc medication manufactured, distributed, or labeled by ALL NATURAL DYNAMICS, Procter & Gamble Manufactura, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

helps prevent hair loss

Warnings

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.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

Water, Sodium laureth sulfate, Sodium lauryl sulfate, Coco Monoethanolamide, Zinc carbonate, Glycol distearate, Dimethicone, Guar hydroxypropyltrimonium chloride, Magnesium sulfate, Sodium benzoate, Magnesium carbonate hydroxide, Benzyl alcohol, Tocopheryl acetate, FD&C Yellow No. 5, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue no. 1

Questions (or comments)?

01-800-717-2413

SPL UNCLASSIFIED SECTION

Dist. by

Procter & Gamble Manufactura, S. de R.L. de C.V.

San Andr`s Atoto No. 326, Naucalpan de Juarez,

Estado de Mexico, MX

www.headandshoulders.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  BREAKAGE PREVENTION
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51769-141
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
Water (UNII: 059QF0KO0R)
Sodium laureth sulfate (UNII: BPV390UAP0)
Sodium lauryl sulfate (UNII: 368GB5141J)
Coco Monoethanolamide (UNII: C80684146D)
Zinc carbonate (UNII: EQR32Y7H0M)
Glycol distearate (UNII: 13W7MDN21W)
Dimethicone (UNII: 92RU3N3Y1O)
Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) (UNII: B16G315W7A)
Magnesium sulfate (UNII: DE08037SAB)
Sodium benzoate (UNII: OJ245FE5EU)
magnesium carbonate hydroxide (UNII: YQO029V1L4)
Benzyl alcohol (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
FD&C Blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51769-141-50	500 mL in 1 BOTTLE, PLASTIC
2	NDC: 51769-141-40	400 mL in 1 BOTTLE, PLASTIC
3	NDC: 51769-141-20	200 mL in 1 BOTTLE, PLASTIC
4	NDC: 51769-141-11	1000 mL in 1 BOTTLE, PLASTIC
5	NDC: 51769-141-18	1180 mL in 1 BOTTLE, PLASTIC
6	NDC: 51769-141-05	50 mL in 1 BOTTLE, PLASTIC
7	NDC: 51769-141-01	10 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/01/2013

Labeler - ALL NATURAL DYNAMICS (962732892)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		812807550	manufacture(51769-141)