OTC Medication Information: Head and Shoulders Cleansing Cucumber

HEAD AND SHOULDERS CLEANSING CUCUMBER- pyrithione zinc 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, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, cucumis sativus (cucumber) fruit water, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

MADE IN U.S.A. of U.S. and/or Imported Ingredients

Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 380 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff scalp & hair shampoo

0% NO DYES

NO PARABENS

NO PHOSPHATES

NO PHTHALATES

CLEANSING CUCMBER WATER SHAMPOO

PURIFIES SCALP AND ALLOWS

YOU TO HAVE HEALTHY HAIR

12.8 FL OZ (380 mL)

HS
(click image for full-size original)
HEAD AND SHOULDERS CLEANSING CUCUMBER
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-530
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
CUCUMBER FRUIT OIL
SODIUM LAURYL SULFATE
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
WATER
SODIUM LAURETH-3 SULFATE
DIMETHICONE
ZINC CARBONATE
GLYCOL DISTEARATE
SODIUM XYLENESULFONATE
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
SODIUM BENZOATE
MAGNESIUM CARBONATE HYDROXIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
CETYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69423-530-38 380 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 03/15/2021
Labeler — The Procter & Gamble Manufacturing Company (004238200)
Establishment
Name Address ID/FEI Operations
The Procter & Gamble Manufacturing Company 005279245 manufacture (69423-530), pack (69423-530)
Establishment
Name Address ID/FEI Operations
The Procter & Gamble Manufacturing Company 081329183 pack (69423-530)

Revised: 01/2023 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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