HEAD AND SHOULDERS MENTHOL FRESH- 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]

WARNINGS AND PRECAUTIONS

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.

Directions

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

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 OUT OF REACH OF CHILDREN

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

Inactive ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, pyrithione zinc, blue 1, red 33.

Questions (or comments)?

01-800-717-2413

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS  MENTHOL FRESH
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51769-133
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 lauryl sulfate (UNII: 368GB5141J)
sodium laureth sulfate (UNII: BPV390UAP0)
glycol distearate (UNII: 13W7MDN21W)
zinc carbonate (UNII: EQR32Y7H0M)
sodium chloride (UNII: 451W47IQ8X)
sodium xylenesulfonate (UNII: G4LZF950UR)
dimethicone (UNII: 92RU3N3Y1O)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium benzoate (UNII: OJ245FE5EU)
magnesium carbonate hydroxide (UNII: YQO029V1L4)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
pyrithione zinc (UNII: R953O2RHZ5)
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: 51769-133-40	400 mL in 1 BOTTLE, PLASTIC
2	NDC: 51769-133-70	700 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/24/2013

Labeler - ALL NATURAL DYNAMICS (962732892)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		812807550	manufacture(51769-133)