FDA.reportPublic FDA data

BIOTOP PROFESSIONAL 02 Eco Dandruff

Manufacturer
G.V. COSMETICS LTD
Effective date
2024-06-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:00:40

Label at a glance#

ProductBIOTOP PROFESSIONAL 02 Eco Dandruff
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

• 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

Storage and handling

• store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2% w/v

Purpose

OTC - PURPOSE SECTION

Antidandruff

Use

INDICATIONS & USAGE SECTION

helps eliminate scalp flaking associated with dandruff

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

+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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G.V. COSMETICS- 032G.V. COSMETICS- 032

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79096-032-102024-01-30C16284748780-11030e365-2722-111a-e063-dadaa90a10e2BIOTOP ® PROFESSIONAL 02 Eco Dandruff
79096-032-252024-01-30C16284748780-11030e365-2722-111a-e063-dadaa90a10e2BIOTOP ® PROFESSIONAL 02 Eco Dandruff
79096-032-502024-01-30C16284748780-11030e365-2722-111a-e063-dadaa90a10e2BIOTOP ® PROFESSIONAL 02 Eco Dandruff

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79096-032BIOTOP PROFESSIONAL 02 ECO DANDRUFF (SALICYLIC ACID) SHAMPOO [G.V. COSMETICS LTD]2Unmatched20240616_be032837-238d-4ddc-a672-b946ea12906f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79096-03279096-032-25, 79096-032-50, 79096-032-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SODIUM COCO-SULFATE3599J29ANHIACT
CHAMOMILEFGL3685T2XIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
AMMONIUM CHLORIDE01Q9PC255DIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT
GLYCOL DISTEARATE13W7MDN21WIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
CHLORPHENESINI670DAL4SZIACT
LAURETH-46HQ855798JIACT
BENZYL BENZOATEN863NB338GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FORMIC ACID0YIW783RG1IACT
SODIUM ACETATE4550K0SC9BIACT
MACADAMIA OIL515610SU8CIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
ALOEV5VD430YW9IACT
SUNFLOWER OIL3W1JG795YIIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
HAIR KERATIN AMINO ACIDSG46579QK1MIACT
LICORICE61ZBX54883IACT
SAGE065C5D077JIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DIPOTASSIUM ANHYDROUS3W5S57M958IACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c9d58611-b821-4e89-bb0d-4d1cade2d9aabe032837-238d-4ddc-a672-b946ea12906f2024-06-07WarningsExact identifier
spl id: c9d58611-b821-4e89-bb0d-4d1cade2d9aa
spl set id: be032837-238d-4ddc-a672-b946ea12906f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.