OTC Medication Information: Dry Scalp Dandruff

DRY SCALP DANDRUFF- pyrithione zinc shampoo
RETAIL BUSINESS SERVICES , LLC

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders® Dry Scalp Care Dandruff Shampoo.

Active ingredients

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

  • do not get into 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 as directed

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • shake well
  • for maximum dandruff control, use everytime you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor

inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Adverse reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guarateed or your money back.

Principal Display Panel

CAREone®

Compare to Head & Shoulders®  Dry Scalp Care Dandruff Shampoo*

DRY SCALP DANDRUFF SHAMPOO

With Added Almond Oil

  • Dandruff Fighting Formula
  • Moisturizes to help relieve dry scalp
  • Pyrithione Zinc

12.5 FL OZ (370 mL)

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DRY SCALP DANDRUFF
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-281
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURYL SULFATE
SODIUM LAURETH SULFATE
GLYCOL DISTEARATE
SODIUM CHLORIDE
ZINC CARBONATE
SODIUM XYLENESULFONATE
AMODIMETHICONE (800 CST)
COCAMIDOPROPYL BETAINE
SODIUM BENZOATE
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MAGNESIUM CARBONATE HYDROXIDE
CITRIC ACID MONOHYDRATE
ALMOND OIL
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72476-281-15 420 mL in 1 BOTTLE, PLASTIC None
2 NDC:72476-281-32 370 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 11/02/2023
Labeler — RETAIL BUSINESS SERVICES , LLC (967989935)
Registrant — Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture (72476-281)
Establishment
Name Address ID/FEI Operations
Vi-Jon 088520668 manufacture (72476-281)

Revised: 11/2023 RETAIL BUSINESS SERVICES , LLC

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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