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| Product NDC Code | 79096-033 | ||||
|---|---|---|---|---|---|
| Drug Name | Biotop professional 02 eco dandruff |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 205173 | ||||
| Application Number | part358H | ||||
| Labeler Name | G.V. COSMETICS LTD | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 1.8% w/v
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 • after using Eco Dandruff shampoo, towel dry your hair, dispense 1 tube into hand, apply the solution directly to your scalp and massage well with your fingertips until dispersed fully and evenly • apply to affected areas one to four times daily or as directed by a doctor • do not wash • recommended use: Women: 1 or 2 tubes per week for 2-3 months Men: 2 or 3 tubes per week for 3 months Preventive Follow-Up Treatment: 1 tube per week for 2 months
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Caprylyl Glycol, Chlorphenesin, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Piroctone Olamine, Polysorbate 20, PPG-26-Buteth-26, Propylene Glycol, SD Alcohol 40, Sodium Hydroxide, Water (Aqua)
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.Use reduces the symptoms of dandruff
Purpose
Information about the drug product’s indications for use.Purpose Antidandruff
Spl product data elements
Usually a list of ingredients in a drug product.BIOTOP PROFESSIONAL 02 Eco Dandruff Salicylic acid SALICYLIC ACID SALICYLIC ACID CAPRYLYL GLYCOL CHLORPHENESIN FD&C BLUE NO. 1 FD&C YELLOW NO. 5 POLYOXYL 40 HYDROGENATED CASTOR OIL PHENOXYETHANOL PIROCTONE OLAMINE POLYSORBATE 20 PPG-26-BUTETH-26 PROPYLENE GLYCOL ALCOHOL SODIUM HYDROXIDE WATER
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.Packaging G.V. COSMETICS- 033
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
ANTIDANDRUFF Soothing Scalp Treatment Parabens, SLS, SLES, Sodium Chloride free Manufactured by G.V. Cosmetics Ltd. 34 Ben-Zion Galis St., Segula, Petah Tikva, Israel 4927934 Made in Israel Responsible person in Europe LL&P Enterprises Ltd. P.O. Box 51445, Limassol 3505, Cyprus Email: [email protected] [email protected] www.biotopworld.com Licensed by the Israeli Ministry of Health www.biotopworld.com | [email protected]
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 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? +1-906-424-4591 You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature
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 Do not use • on or by children • in case of damaged scalp • if sensitive to any of its ingredients When using this product • do not get into eyes. In case of contact, 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 • any irritation appears Keep 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