Label: BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid solution
- NDC Code(s): 79096-033-11
- Packager: G.V. COSMETICS LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 7, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
• on or by children
• in case of damaged scalp
• if sensitive to any of its ingredientsWhen using this product
• do not get into eyes. In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor if
• condition worsens or does not improve after regular use of this product as directed
• any irritation appears -
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 - Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
ANTIDANDRUFF
Soothing Scalp Treatment
Parabens, SLS, SLES, Sodium Chloride freeManufactured by G.V. Cosmetics Ltd.
34 Ben-Zion Galis St., Segula, Petah Tikva,
Israel 4927934Made in Israel
Responsible person in Europe
LL&P Enterprises Ltd.
P.O. Box 51445, Limassol 3505, Cyprus
Email: christiana@llpenterprises.comInfo@biotopworld.com
www.biotopworld.comLicensed by the Israeli Ministry of Health
www.biotopworld.com | Info@biotopworld.com - Packaging
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INGREDIENTS AND APPEARANCE
BIOTOP PROFESSIONAL 02 ECO DANDRUFF
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79096-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.8 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PHENOXYETHANOL (UNII: HIE492ZZ3T) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) POLYSORBATE 20 (UNII: 7T1F30V5YH) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79096-033-11 6 in 1 BOX 01/16/2023 06/30/2025 1 11 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 01/16/2023 06/30/2025 Labeler - G.V. COSMETICS LTD (649551330) Establishment Name Address ID/FEI Business Operations G.V. COSMETICS LTD 649551330 manufacture(79096-033)