Label: ALCO HAND SANITIZER- alcohol gel

  • NDC Code(s): 11429-1003-1, 11429-1003-2, 11429-1003-3, 11429-1003-4, view more
    11429-1003-5, 11429-1003-6, 11429-1003-7, 11429-1003-8
  • Packager: Woodbine Products Company
  • 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 17, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Sanitizer

  • INDICATIONS & USAGE

    Uses:

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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.

  • STORAGE AND HANDLING

    Other Information:

    Store below 110 F (43 C).

    May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    Alco-Gel Hand Sanitizer

    Evaporates quickly

    Kills 99.99% of common germs that can cause illness

    Leaves hands smooth and refreshed

    PK

    Woodbine Products Company

    915 West Smith Road

    Medina, Ohio 44256

    www.woodbineproducts.com

    Made in the U.S.A.

    Stock # 4330        10000 ml (34 fl. oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    ALCO HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1003
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1003-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    2NDC:11429-1003-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    3NDC:11429-1003-41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    4NDC:11429-1003-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    5NDC:11429-1003-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    6NDC:11429-1003-51892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
    7NDC:11429-1003-63785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
    8NDC:11429-1003-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!