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Head and shoulders tea tree oil 2in1 - Medication Information

Product NDC Code 69423-417
Drug Name

Head and shoulders tea tree oil 2in1

Type Brand
Active Ingredients
Pyrithione zinc 1 g/100ml
Route TOPICAL
Dosage Form LOTION/SHAMPOO
RxCUI drug identifier 209884,
1043244
Application Number M032
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-417-37 370 ml in 1 bottle, plastic (69423-417-37)
69423-417-40 400 ml in 1 bottle, plastic (69423-417-40)
69423-417-83 835 ml in 1 bottle, pump (69423-417-83)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Pyrithione zinc 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stem oil, melaleuca alternifolia (tea tree) leaf oil, yellow 5, blue 1

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps prevent recurrence of flaking and itching associated with dandruff.

Purpose

Information about the drug product’s indications for use.
Purpose Anti-dandruff

Spl product data elements

Usually a list of ingredients in a drug product.
Head and Shoulders Tea Tree Oil 2in1 Pyrithione Zinc MENTHA ARVENSIS LEAF OIL TEA TREE OIL FD&C YELLOW NO. 5 GLYCOL DISTEARATE WATER SODIUM LAURYL SULFATE SODIUM LAURETH-3 SULFATE ZINC CARBONATE SODIUM CHLORIDE SODIUM XYLENESULFONATE DIMETHICONE COCAMIDOPROPYL BETAINE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE FD&C BLUE NO. 1 PYRITHIONE ZINC PYRITHIONE ZINC MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo + conditioner TEA TREE OIL 2in1 12.5 FL OZ (370 mL) HS

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
For external use only.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions (or comments)? 1-800-723-9569

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API