HEAD AND SHOULDERS 2IN1 TEA TREE- pyrithione zinc shampoo

Head and Shoulders 2in1 Tea Tree by

Drug Labeling and Warnings

Head and Shoulders 2in1 Tea Tree 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

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, sodium laureth sulfate, cocamide MEA, sodiumxylenesulfonate, zinc carbonate, glycol distearate, sodiumlauryl sulfate, cocamidopropyl betaine, dimethicone, fragrance, sodiumchloride, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesiumcarbonate hydroxide, cetyl alcohol, polyquaternium-76, mentha piperita (peppermint) oil, mentha arvensis leaf oil,melaleuca alternifolia (tea tree) leaf oil,methylchloroisothiazolinone, methylisothiazolinone, yellow5, blue 1.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1.18 L Bottle Label

head &
shoulders ®

pyrithione zinc

dandruff shampoo + conditioner

2in1

Tea Tree

infused with tea tree oil

& cooling mint complex

FLAKE FREE.*

UP TO 100%

GUARANTEED

40 FL OZ (1.18 L)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS 2IN1 TEA TREE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-265
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TEA TREE OIL (UNII: VIF565UC2G)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MENTHOL (UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-265-11	1180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2018	09/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/01/2018	09/14/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		005279245	manufacture(69423-265) , pack(69423-265)