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Royal oils by head and shoulders scalp care dual pack - Medication Information

Product NDC Code 84126-003
Drug Name

Royal oils by head and shoulders scalp care dual pack

Type Brand
Dosage Form KIT
RxCUI drug identifier 209884,
1043014,
1043244,
1044465
Application Number M032
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
84126-003-01 1 kit in 1 cello pack (84126-003-01) * 380 ml in 1 bottle, plastic (69423-608-38) * 400 ml in 1 bottle, plastic (69423-571-40)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Pyrithione zinc 1% Active ingredient Pyrithione zinc 0.5%

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. Directions for best results use at least twice a week or as directed by a doctor. apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium citrate, fragrance, sodium chloride, cocos nucifera (coconut) oil, vinegar†, acrylates copolymer, polyquaternium-10, dimethiconol, sodium benzoate, citric acid, sodium salicylate. Inactive ingredients Water, stearyl alcohol, dimethicone, behentrimonium chloride, cetyl alcohol, cocos nucifera (coconut) fruit extract, vinegar†, zea mays (corn) silk extract, fragrance, phenoxyethanol, benzyl alcohol, citric acid, methylchloroisothiazolinone, methylisothiazolinone.

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. Uses helps prevent recurrence of flaking and itching associated with dandruff.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Royal Oils by Head and Shoulders Scalp Care Dual Pack Pyrithione Zinc Royal Oils by Head and Shoulders Sulfate Free Scalp Care Pyrithione Zinc POLYQUATERNIUM-10 (30000 MPA.S AT 2%) PYRITHIONE ZINC PYRITHIONE ZINC WATER LAURAMIDOPROPYL BETAINE SODIUM CHLORIDE DIMETHICONOL (50000 CST) SODIUM BENZOATE COCONUT OIL SODIUM COCOYL ISETHIONATE CITRIC ACID MONOHYDRATE SODIUM LAUROYL SARCOSINATE SODIUM CITRATE ACETIC ACID SODIUM SALICYLATE Royal Oils by Head and Shoulders Moisture Renewal Scalp Balancing Conditioner Pyrithione Zinc STEARYL ALCOHOL PYRITHIONE ZINC PYRITHIONE ZINC WATER CETYL ALCOHOL PHENOXYETHANOL BENZYL ALCOHOL METHYLISOTHIAZOLINONE DIMETHICONE CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE COCONUT CORN SILK BEHENTRIMONIUM CHLORIDE ACETIC ACID

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 - Kit ROYAL OILS by head & shoulders ® Shampoo & Conditioner Inside pyrithione zinc dandruff shampoo ROYAL OILS by head & shoulders SULFATE FREE SCALP CARE SHAMPOO ROYAL OILS by head & shoulders pyrithione zinc dandruff conditioner MOISTURE RENEWAL SCALP BALANCING CONDITIONER 1 PYRITHIONE ZINC DANDRUFF SHAMPOO 12.8 FL OZ (380 mL) 1 PYRITHIONE ZINC DANDRUFF CONDITIONER 13.5 FL OZ (400 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.
ROYAL OILS by head & shoulders SULFATE FREE SCALP CARE SHAMPOO Drug Facts ROYAL OILS by head & shoulders MOISTURE RENEWAL SCALP BALANCING CONDITIONER Drug Facts Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202

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. 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 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. 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. 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. 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