Label: ARIS HAND SANITIZER- isopropyl alcohol spray

  • 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 9, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl alcohol 75% v/v

  • Purpose

    Antimicrobial

  • Uses.

    ▪ Hand sanitizer spray to help reduce bacteria on the skin that could cause disease.

    ▪ Recommended for repeated use.

  • Warnings.

    Flammable. Keep away from fire or flame

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a poison center right away.

  • Directions.

    ▪ Spray directly on hands and rub in thoroughly until dry.

    ▪ Children under 6 years of age should be supervised when using Aris Hand Sanitizer Spray.

  • Other Information.

    ▪ Store below 110°F(43°C)

    ▪ May discolour certain fabrics or surfaces

  • Inactive Ingredients

    Water (Aqua), Tocopheryl Acetate (Vitamin E), Caprylyl Glycol, Glycerin, Isopropyl Myristate, Fragrance (Parfum).

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING WITH VITAMIN E

    KILLS UP TO 99.99% GERMS

    TRIPLE ACTION MOISTURIZERS

    Leaves Hand Feeling Soft

    KILLS UP TO 99.99% of most common germs that may make you sick

    Produced by Winner Manufacturing

    Made in UAE

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ARIS HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79260-472
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79260-472-0225 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    2NDC:79260-472-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    3NDC:79260-472-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    4NDC:79260-472-25250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    5NDC:79260-472-50500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    6NDC:79260-472-511000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/06/2020
    7NDC:79260-472-555000 mL in 1 CAN; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - WINNER MANUFACTURING (561423928)
    Establishment
    NameAddressID/FEIBusiness Operations
    WINNER MANUFACTURING561423928manufacture(79260-472)
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