Head and Shoulders ® Men Advanced Series Refreshing Menthol Shampoo

Head and Shoulders ® Men Advanced Series Refreshing Menthol Shampoo

Drug Labeling and Warnings

Drug Details

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HEAD AND SHOULDERS MEN ADVANCED SERIES REFRESHING MENTHOL- pyrithione zinc lotion/shampoo 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Head and Shoulders ® Men Advanced Series Refreshing Menthol Shampoo

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, zinc carbonate, glycol distearate, cocamide MEA, cocamidopropyl betaine, fragrance, sodium chloride, sodium xylenesulfonate, dimethicone,menthol, guar hydroxypropyltrimonium chloride, sodium benzoate,

polyquaternium-10, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, methylchloroisothiazolinone,methylisothiazolinone, blue 1, red 33.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 650 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff shampoo

MEN

ADVANCED SERIES™

REFRESHING MENTHOL

cools &

energizes scalp

FLAKE FREE.*

UP TO 100%

GUARANTEED^

21.9 FL OZ (650 mL)

HEAD AND SHOULDERS MEN ADVANCED SERIES REFRESHING MENTHOL 
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-311
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
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MENTHOL (UNII: L7T10EIP3A)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
CETYL ALCOHOL (UNII: 936JST6JCN)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-311-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/29/2018
2	NDC: 69423-311-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/29/2018
3	NDC: 69423-311-93	930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/29/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2018

Document Id: 7c4d932b-92c7-4a8d-e053-2a91aa0ae69a

34390-5

Set id: 7c4dacd2-d6aa-24c2-e053-2a91aa0a8c14

Version: 1

Effective Time: 20181205

 

The Procter & Gamble Manufacturing Company