Label: BIOSALUT HAND SANITIZER ADVANCED- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 14, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses • Decrease bacteria on the skin.

  • Warnings

    For external use only

    Flammable. Keep away from heat and flame.

    When using this product, ?avoid contact with eye. In case of contact, flush with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions• Wet hands thoroughly with product and allow to dry. • Children under 6 years of age, use only under adult supervision.

  • STORAGE AND HANDLING

    Other Information • Do not store above 105°F (43°C) • May discolor some fabrics and surfaces.

  • INACTIVE INGREDIENT

    Inactive Ingredients ?AQUA, PROPYLENE GLYCOL, GLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PARFUM, AMINOMETHYL PROPANOL, CINNAMYL ALCOHOL, HEXYL CINNAMAL, D-LIMONENE, COUMARIN, BENZYL SALICYLATE, GERANIOL, ALOE BARBADENSIS LEAF EXTRACT, SORBITOL, POTASSIUM SORBATE, SODIUM BENZOATE. AFE: 2.02.100-5

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    Disinfects while moisturizes, leaving hands feeling refreshed.

    Manufactured by : Phitoteraphia Biofitogenia Laboratorial Biota

    Ltda Rua Maria de Andrade 79A . CEP 26261 - 200 Nova Iguaçu/RJ. CNPJ:

    00.104.603/0001-33. Brazilian Industry • Téc. Resp:

    Eni Figueiredo CRQ III 03212976 • Imported and distributed in USA by: Brazilian Hair LLC. 1275

    Bloomfield Ave. Bldg. 7 Unit 48 Fairfield, NJ 07004.

    Ph: +1 800 519 2946 -info@embellezeusa.com - www.novexhaircare.com Origin/Origen: Brazil

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    BIOSALUT HAND SANITIZER ADVANCED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75753-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    COUMARIN (UNII: A4VZ22K1WT)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75753-300-09140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    2NDC:75753-300-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - Brazilian Hair Llc (009780655)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHITOTERAPHIA BIOFITOGENIA LABORATORIAL BIOTA LTDA678448921manufacture(75753-300)
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