HEAD AND SHOULDERS TEA TREE OIL 2IN1- pyrithione zinc lotion/shampoo

Head and Shoulders Tea Tree Oil 2in1 by

Drug Labeling and Warnings

Head and Shoulders Tea Tree Oil 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

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, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, dimethicone, fragrance, sodium chloride, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76, mentha piperita (peppermint) oil, mentha arvensis leaf oil, melaleuca alternifolia (tea tree) leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow5, blue1.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff

shampoo + conditioner

TEA TREE
OIL

2in1

13.5 FL OZ

(400 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS TEA TREE OIL 2IN1 
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-417
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
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CETYL ALCOHOL (UNII: 936JST6JCN)
TEA TREE OIL (UNII: VIF565UC2G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH-3 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)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-417-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/21/2019
2	NDC: 69423-417-95	950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/21/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)