Label: HAND SANITIZER- alcohol spray

  • NDC Code(s): 70983-025-01, 70983-025-02, 70983-025-03, 70983-025-04
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 31, 2023

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  • Active Ingredient(s)

    Alcohol 68% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Product Identity

    Hand Sanitizer - Antibacterial Spray

    2 fl oz | 60 ml

    3.4 fl oz | 100 ml
    6.8 fl oz | 200 ml
    33.8 fl oz | 1 L

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. If contact occurs with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Spray enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    aloe barbadensis leaf juice powder, glycerin, lime oil, purified water.

  • Hand Sanitizer Spray - Package Label

    60 mL NDC: 70983-025-04

    HandSantizer_60ml

    100 mL NDC: 70983-025-01 Saje 100 ml Hand Sanitizer

    200 mL NDC: 70983-025-02 Saje 200 ml Hand Sanitzer

    1 L NDC: 70983-025-03 Saje 1L Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIME OIL (UNII: UZH29XGA8G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-025-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    2NDC:70983-025-02200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    3NDC:70983-025-031000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/26/2020
    4NDC:70983-025-0460 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/01/2020
    Labeler - Saje Natural Business Inc. (080465432)
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