Label: ALCOGEL HAND SANITIZER- alcohol gel

  • NDC Code(s): 82825-001-07
  • Packager: Erie Cotton Products 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 June 30, 2022

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  • Active ingredient

    Ethyl Alcohol 70%v/v

  • Purpose

    Sanitizer

  • Uses:

    For hand sanitizng to decrease bacteria on the skin.

    Recommended for repeated use.

  • Warnings: Flammable. Keep away from fire or flame.

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if 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:

    Apply gel to dry hands and rub thoroughly until hands are dry.

    Do not rinse or wipe gel off.

    Should solution enter eyes, rinse immediately with water.

  • Other Information:

    Store below 110 F (43 C).

    May discolor certain fabrics or surfaces.

  • Inactive ingredients:

    Water, Propylene Glycol, PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Triethanolamine, Carbopol and Fragrance

  • PRINCIPAL DISPLAY PANEL

    ALCOGeL

    Hand Sanitizer

    Made in the USA

    Distributed By:

    Erie Cotton

    www.ErieCotton.com

    800.289.4737

    Stock # PK-AGEL750-ECP 750ml (25 fl.oz.)

    container labelf

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  • INGREDIENTS AND APPEARANCE
    ALCOGEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82825-001
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82825-001-07750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2022
    Labeler - Erie Cotton Products Inc. (125476317)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(82825-001)
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