Label: ANIOSGEL 85 NPC- alcohol gel 

  • NDC Code(s): 62169-203-12, 62169-203-17
  • Packager: Laboratoires Anios
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/14

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

  • INDICATIONS & USAGE

    Indications & Usage:

    HYDROALCOHOLIC ANTISEPTIC GEL FOR SKIN AND HANDS

    Active Ingredients Purpose
    Ethanol 70.0% (w/w) ....................................Antisepsis

    Close
  • INSTRUCTIONS FOR USE

    Instructions for Use/Directions

    Hygienic Treatment: Apply 3 ml of gel to cupped palm of hands. Rub fingertips and hands thoroughly until completely dry, for at least 30 seconds.

    Surgical disinfection: 2 x 3 ml for a hand rubbing time of 2 x 45 seconds.

    • Do not rinse

    For Dosage and Administration, please refer to "INSTRUCTIONS FOR USE SECTION"

    Close
  • WARNINGS AND PRECAUTIONS

    Warnings and Precautions
    For external use only
    • Do not swallow
    • Keep away from heat source
    • If accidental eye contact occurs, rinse thoroughly with water
    • If irritation persists, consult a physician

    ln case of ingestion, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

    Close
  • PURPOSE

    OTC Purpose/Use

    • Hygienic treatment
    • Surgical disinfection

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Inert ingredients 30.0% (w/w)

    Close
  • WARNINGS

    For Warnings, please refer to "WARNINGS AND PRECAUTIONS SECTION"

    Close
  • PRINCIPAL DISPLAY PANEL

    FRONT LABEL
    Front Label

    BACK LABEL

    Back Label

    Close
  • INGREDIENTS AND APPEARANCE
    ANIOSGEL 85  NPC
    ethanol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62169-203
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 377.5 mL  in 500 mL
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin 122.5 mL  in 500 mL
    Product Characteristics
    Color      Score     
    Shape FREEFORM Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62169-203-12 12 in 1 PACKAGE
    1 NDC:62169-203-17 500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/01/2014
    Labeler - Laboratoires Anios (274758465)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratoires Anios 274758465 manufacture(62169-203)
    Close