Head and Shoulders ® Men Advanced Series Refreshing 2in1 Menthol Shampoo

Head and Shoulders ® Men Advanced Series Refreshing 2in1 Menthol Shampoo

Drug Labeling and Warnings

Drug Details

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HEAD AND SHOULDERS MEN ADVANCED SERIES REFRESHING 2IN1 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 2in1 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, cocamidopropylbetaine, dimethicone, fragrance, sodium chloride, sodium xylenesulfonate, 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, blue1, 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 + CONDITIONER

2in1

MEN

ADVANCED SERIES

REFRESHING MENTHOL

COOLS &

ENERGIZES SCALP

FLAKE FREE

UP TO 100%

GUARANTEED

21.9 FL OZ (650 mL)

HS

HEAD AND SHOULDERS MEN ADVANCED SERIES REFRESHING 2IN1 MENTHOL 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69423-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69423-312-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2018
2NDC: 69423-312-65650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/29/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2018
 
The Procter & Gamble Manufacturing Company


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