Label: ARIAS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 11, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 72% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin

    • recommended for repeated use

    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

    • in children less than 2 months of age

    • on open skin wounds

    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

    • irritation and redness develop

    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping

    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)

    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    water, glycerin, diethylphthalate, carbomer, fragrance, triethanolamine, tocopherol acetate, aloe vera extract

  • Questions?

    +1-917- 719-0285

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    LARA DUTTA

    REFRESHING GEL

    With Moisturizers, Vitamin E & Aloe Vera Extract

    Distributed By: SCENTIALS BEAUTYCARE & WELLNESS PVT. LTD.

    1001/1002, LOTUS GRANDEUR, OFF VEERA DESAI ROAD, ANDHERI WEST,

    MUMBAI 400053, INDIA.

    MADE IN INDIA

    care@scentialsworld.com

    www.scentialsworld.com

    scentials_world      @scentialsworld

    Arias is the registered trademark of Arias Branding LLP.

    Imitation of Graphics/Pack Design is a punishable offence.

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ARIAS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76603-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76603-100-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:76603-100-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:76603-100-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:76603-100-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    5NDC:76603-100-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    6NDC:76603-100-30300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    7NDC:76603-100-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - Scentials Beautycare And Wellness Private Limited (861188203)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.P.Y. AGRO INDUSTRIES LIMITED676197931manufacture(76603-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Zuofun Cosmetics Co., Ltd530135094manufacture(76603-100)
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