BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid solution

BIOTOP PROFESSIONAL 02 Eco Dandruff by

Drug Labeling and Warnings

BIOTOP PROFESSIONAL 02 Eco Dandruff by is a Otc medication manufactured, distributed, or labeled by G.V. COSMETICS LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BIOTOP PROFESSIONAL 02 ECO DANDRUFF 
salicylic acid solution

Product 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)