BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid shampoo 
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 2% w/v

Purpose

Antidandruff

Use

helps eliminate scalp flaking associated with 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

• gently massage a generous amount of shampoo into the scalp until a lather forms
• leave in for 5 minutes and rinse
• for best results use at least twice a week or as directed by a doctor

Other information

• store at room temperature

Inactive ingredients

Water (Aqua), Sodium Coceth Sulfate, Chamomile (Chamomilla recutita) Flower Extract, Panthenol, Phenoxyethanol, PEG -150 Distearate, Ammonium Chloride, Piroctone Olamine, Polyquaternium-10, Glycol Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Chlorphenesin, Laureth-4, Benzyl Benzoate, Caprylyl Glycol, Benzyl Salicylate, Cocamidopropyl Betaine, Citric Acid, Formic Acid, Sodium Acetate, Macadamia (Macadamia ternifolia) Seed Oil, Sea Buckthorn (Hippophae rhamnoides) Fruit Oil, Aloe (Aloe barbadensis) Juice, Sunflower (Helianthus annuus) Seed Oil, SD Alcohol 40, Glycerin, Hydrolyzed Keratin, Licorice (Glycyrrhiza glabra) Root Extract, Sage (Salvia officinalis) Extract, Sodium Benzoate, Benzyl Alcohol, Dipotassium EDTA, Potassium Sorbate

Questions?

+1-906-424-4591
You may also report serious side effects to this phone number.
Mon - Fri 9:00 AM - 5:00 PM

Soothes Dry Scalp

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

Packaging

G.V. COSMETICS- 032

BIOTOP PROFESSIONAL 02 ECO DANDRUFF 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79096-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
CHAMOMILE (UNII: FGL3685T2X)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
LAURETH-4 (UNII: 6HQ855798J)  
BENZYL BENZOATE (UNII: N863NB338G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FORMIC ACID (UNII: 0YIW783RG1)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
MACADAMIA OIL (UNII: 515610SU8C)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
ALOE (UNII: V5VD430YW9)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HAIR KERATIN AMINO ACIDS (UNII: G46579QK1M)  
LICORICE (UNII: 61ZBX54883)  
SAGE (UNII: 065C5D077J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DIPOTASSIUM ANHYDROUS (UNII: 3W5S57M958)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79096-032-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2023
2NDC:79096-032-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2023
3NDC:79096-032-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/05/2023
Labeler - G.V. COSMETICS LTD (649551330)
Establishment
NameAddressID/FEIBusiness Operations
G.V. COSMETICS LTD649551330manufacture(79096-032)

Revised: 1/2023
Document Id: cfe3debe-13a6-4500-b6f0-b00df18bd629
Set id: be032837-238d-4ddc-a672-b946ea12906f
Version: 1
Effective Time: 20230104
 
G.V. COSMETICS LTD