BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid shampoo

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 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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BIOTOP PROFESSIONAL 02 ECO DANDRUFF 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79096-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79096-032-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2023	06/30/2025
2	NDC: 79096-032-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2023	06/30/2025
3	NDC: 79096-032-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2023	06/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/05/2023	06/30/2025

Labeler - G.V. COSMETICS LTD (649551330)

Establishment
Name	Address	ID/FEI	Business Operations
G.V. COSMETICS LTD		649551330	manufacture(79096-032)