HEAD AND SHOULDERS 2IN1 INSTANT OIL CONTROL- pyrithione zinc lotion/shampoo

Head and Shoulders 2in1 by

Drug Labeling and Warnings

Head and Shoulders 2in1 by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

INDICATIONS & USAGE

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

Inactive ingredients

Water, sodiumlaureth sulfate, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodiumlauryl sulfate, cocamidopropyl betaine, dimethicone, fragrance, sodium chloride, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76, citrus limon(lemon) fruit

extract, methylchloroisothiazolinone, methylisothiazolinone, eucalyptol, camphor, yellow5, blue 1.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff

shampoo + conditioner

INSTANT oil control

2in1

controls hair and scalp oils

INFUSED WITH MANGO & CITRUS ESSENCE

FLAKE FREE.*
UP TO 100%
GUARANTEED^

12.8 FL OZ (380mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS 2IN1  INSTANT OIL CONTROL
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-345
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
EUCALYPTOL (UNII: RV6J6604TK)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL (UNII: L7T10EIP3A)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LEMON (UNII: 24RS0A988O)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-345-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014
2	NDC: 37000-345-66	665 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014	02/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2014

Labeler - The Procter & Gamble Manufacturing Company (004238200)