Label: INTROSTEM SANITIZING WIPE- isopropyl alcohol solution

  • 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 May 25, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Isopropyl Alcohol 70% 

  • Purpose

    Antiseptic

  • Use

    For cleaning and disinfecting. Reduce bacteria than potentially can cause disease

  • Warnings

    For external use only.

    Flammable. Keep away from fire and flame

  • Do not use

    Do not use on

    • Children less than 2 months of age
    • Open skin wounds
  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops and persists

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply to hands as needed

    Discard after single use

  • Other information

    Do not flush

    Store at room temperature

  • Inactive ingredients

    Water, Vitamin E, Glycerin, Aloe Extract, Lavender Essence, Vitis Vinefera (Grape) Fruit Cell Extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INTROSTEM SANITIZING WIPE 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75177-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL1.155 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75177-052-01200 in 1 BOX05/25/2020
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - Herstyler, Inc. (837505481)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(75177-052)
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