Label: BIOTOP PROFESSIONAL 02 ECO DANDRUFF- salicylic acid shampoo

  • NDC Code(s): 79096-032-10, 79096-032-25, 79096-032-50
  • Packager: G.V. COSMETICS LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 4, 2023

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  • 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

    G.V. COSMETICS- 032

  • INGREDIENTS AND APPEARANCE
    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)
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