BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid solution 
G.V. COSMETICS LTD

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.

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BIOTOP® PROFESSIONAL 02 Eco Dandruff

Drug Facts

Active ingredient

Salicylic acid 1.8% w/v

Purpose

Antidandruff

Use

reduces the symptoms of dandruff

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.

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

• store at room temperature

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)

Questions?

+1-906-424-4591
You may also report serious side effects to this phone number.

Mon - Fri 9:00 AM - 5:00 PM

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: christiana@llpenterprises.com

Info@biotopworld.com
www.biotopworld.com

Licensed by the Israeli Ministry of Health
www.biotopworld.com | Info@biotopworld.com

Packaging

G.V. COSMETICS- 033

BIOTOP PROFESSIONAL 02 ECO DANDRUFF 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79096-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79096-033-116 in 1 BOX01/16/2023
111 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/16/2023
Labeler - G.V. COSMETICS LTD (649551330)
Establishment
NameAddressID/FEIBusiness Operations
G.V. COSMETICS LTD649551330manufacture(79096-033)

Revised: 2/2023
Document Id: 4e1acbdb-18f6-4e25-b213-4c2290da9383
Set id: a59909da-c42d-4ad2-9f23-7c4d6cc56329
Version: 2
Effective Time: 20230207
 
G.V. COSMETICS LTD