OTC Medication Information: Head and Shoulders Men Advanced Series Refreshing 2in1 Menthol

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.

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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, dimethicone, cocamidopropyl
betaine, sodium xylenesulfonate, fragrance, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide,mentha piperita (peppermint) flower/leaf/stemoil, mentha arvensis leaf/stem oil, blue 1, red 33

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 370 mL Bottle Label

head &

shoulders

PYRITHIONE ZINC DANDRUFF

SHAMPOO + CONDITIONER

2in1

MEN

REFRESHING MENTHOL

Intensely cools &

energizes scalp

FLAKE FREE

UP TO 100%

GUARANTEED

12.5 FL OZ (370 mL)

HS
(click image for full-size original)
HEAD AND SHOULDERS MEN ADVANCED SERIES REFRESHING 2IN1 MENTHOL
pyrithione zinc lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-312
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
D&C RED NO. 33
MENTHOL
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MENTHA ARVENSIS LEAF OIL
PEPPERMINT OIL (PEPPERMINT)
WATER
SODIUM LAURETH-3 SULFATE
GLYCOL DISTEARATE
ZINC CARBONATE
SODIUM CHLORIDE
SODIUM XYLENESULFONATE
COCAMIDOPROPYL BETAINE
DIMETHICONE
SODIUM BENZOATE
MAGNESIUM CARBONATE HYDROXIDE
MENTHA PIPERITA LEAF
SODIUM LAURYL SULFATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69423-312-38 380 mL in 1 BOTTLE, PLASTIC None
2 NDC:69423-312-65 650 mL in 1 BOTTLE, PLASTIC None
3 NDC:69423-312-37 370 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M032 11/29/2018
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 03/2023 The Procter & Gamble Manufacturing Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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