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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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
• on or by children • in case of damaged scalp
• if sensitive to any of its ingredientsWhen 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 - Directions
- Other information
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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
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INGREDIENTS AND APPEARANCE
BIOTOP PROFESSIONAL 02 ECO DANDRUFF
salicylic acid shampooProduct 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 2 NDC:79096-032-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2023 3 NDC:79096-032-10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/05/2023 Labeler - G.V. COSMETICS LTD (649551330) Establishment Name Address ID/FEI Business Operations G.V. COSMETICS LTD 649551330 manufacture(79096-032)