Label: ISOPROPYL ALCOHOL solution

  • NDC Code(s): 0168-0907-60
  • Packager: Fougera Pharmaceuticals Inc.
  • 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 April 28, 2020

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  • Drug Facts

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only USP grade ingredients in the preparation of the product, consistent with World Health Organization (WHO) recommendations.

    The firm does not add other active or inactive ingredients.

  • Active ingredient(s)

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Uses

    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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Place 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° to 30°C (59° to 86°F)
    ▪
    Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    glycerin, hydrogen peroxide, purified water USP.

  • Package/Label Principal Display Panel - 60mL Bottle

    NDC 0168-0907-60

    E.FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Isopropyl Alcohol Antiseptic 75% Topical Solution

    Hand Sanitizer

    Non-sterile Solution

    60 mL

    60mLBottlelabel
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0907
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0907-6060 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 - Fougera Pharmaceuticals Inc. (043838424)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fougera Pharmaceuticals Inc.174491316MANUFACTURE(0168-0907)
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