HEAD AND SHOULDERS RENEWING CLEAN- 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 ALL NATURAL DYNAMICS, Procter & Gamble Manufactura, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

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, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Questions (or comments)?

01-800-717-2413

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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  RENEWING CLEAN
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51769-139
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
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)
sodium chloride (UNII: 451W47IQ8X)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
sodium xylenesulfonate (UNII: G4LZF950UR)
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
1	NDC: 51769-139-40	400 mL in 1 BOTTLE, PLASTIC
2	NDC: 51769-139-50	500 mL in 1 BOTTLE, PLASTIC
3	NDC: 51769-139-20	200 mL in 1 BOTTLE, PLASTIC
4	NDC: 51769-139-70	700 mL in 1 BOTTLE, PLASTIC
5	NDC: 51769-139-11	1000 mL in 1 BOTTLE, PLASTIC
6	NDC: 51769-139-18	1180 mL in 1 BOTTLE, PLASTIC
7	NDC: 51769-139-05	50 mL in 1 BOTTLE, PLASTIC
8	NDC: 51769-139-01	10 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/29/2013

Labeler - ALL NATURAL DYNAMICS (962732892)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		810007526	manufacture(51769-139)