Label: F(X)L SKIN CARE HAND SANITIZER- alcohol gel

  • NDC Code(s): 65113-1001-1, 65113-1001-2, 65113-1001-3, 65113-1001-4
  • Packager: G.S. COSMECEUTICAL USA, 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 January 6, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethanol 70% v/v

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to reduce the germs on skin

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product

    • keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.
    • do not inhale or ingest.

    Stop use and ask a doctor if irritation or rash occurs and lasts.

    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
    • for children under 6, use only under adult supervision
  • Other Information

    • do not store above 104° F (40° C)
    • may discolor certain fabrics or surfaces
  • Inactive Ingredients

    Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    G.S. Cosmeceutical USA, Inc.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    f(x)l™
    skincare

    Hand Sanitizer

    Kills 99.9% of Germs

    Unscented Gel

    16 FL OZ / 473 mL

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    F(X)L SKIN CARE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-1001
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Semuloparin (UNII: 4QW4AN84NQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65113-1001-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:65113-1001-2237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:65113-1001-3473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:65113-1001-4946 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 - G.S. COSMECEUTICAL USA, INC. (017014734)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(65113-1001)
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!