Label: COMMONWEALTH FRAGRANCE FREE HAND SANITIZER GEL- 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 October 13, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

  • 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

    • on children less than 2 months of age

    • on open wounds

    When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask 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 under 105° F

  • INACTIVE INGREDIENT

    Inactive ingredients Hydroxyethyl cellulose, Propylene glycol, Water

  • QUESTIONS

    Questions? 1-937-470-5755

    You can also report serious side effects to this phone number Mon - Fri 9:00am - 5:00 pm

  • SPL UNCLASSIFIED SECTION

    Fragrance Free

    Tough on Germs

    Not on Hands

    Silky Smooth Formulation

    Non Irritating

    NATURAL INGREDIENT FORMULA

    SULFATE - FREE

    PARABEN - FREE

    VEGAN

    MADE IN USA

    FDA REGISTERED

    Manufactured by: Commonwealth Homes Inc, Centerville, Ohio, 45370

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    COMMONWEALTH FRAGRANCE FREE HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73802-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73802-118-303785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/10/2020
    Labeler - Commonwealth Homes, Inc. (127801525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commonwealth Homes, Inc.127801525manufacture(73802-118)
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