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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2023
If you are a consumer or patient please visit this version.
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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 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 final part358H 01/16/2023 Labeler - G.V. COSMETICS LTD (649551330) Establishment Name Address ID/FEI Business Operations G.V. COSMETICS LTD 649551330 manufacture(79096-033)
