Label: HAND SANITIZER 70% GEL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 16, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient[s]

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use[s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    in children less than 2 months of age

    on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    • Store between 15-30°C (59-83°F)

    • Avoid freezing and excessive heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, monoethanolamine, acrylate copolymer, fragrance, water

  • SPL UNCLASSIFIED SECTION

    Alcohol Antiseptic 70% Gel

    Non-sterile Solution

    UN1170

    Hazard Class 3

    Packing Group II

    FLAMMABLE LIQUID

    Signal Word: Danger

    Proper Shipping Name: Ethanol solution

    HAZARD STATEMENTS:
    H225 - Highly flammable liquid and vapor.
    H319 - Causes serious eye irritation.
    H336 – May cause drowsiness or dizziness

    PRECAUTION STATEMENTS:
    P210 - Keep away from heat/sparks/open flames/hot surfaces. No smoking.
    P233 - Keep container tightly closed.
    P240 - Ground and bond container and receiving equipment
    P241+P242 - Use explosion-proof electrical, ventilating and lighting equipment. Use only non-sparking tools.
    P243 - Take precautionary measures against static discharge.
    P261 - Avoid breathing fumes, mist and vapor.
    P264 - Wash hands and other exposed skin areas thoroughly after handling.
    P271 - Use only outdoors or in a well-ventilated area.
    P280 - Wear protective gloves/protective clothing/eye protection/face protection.
    P303+P361+P353 - IF ON SKIN (or hair): Remove immediately all contaminated clothing. Rinse skin with water or shower.
    P304+P340+P312 - IF INHALED: Remove victim to fresh air and keep at rest in a comfortable position for breathing. Call a POISON CENTER or doctor if you feel unwell.
    P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
    P370+P378 - In case of fire: Use water fog, foam, dry chemical or carbon dioxide for extinction.
    P405+P403+P233+P235 - Store locked up in a well-ventilated place. Keep container tightly closed. Keep cool.
    P501 - Dispose of contents/container to authorized hazardous or special waste collection point in accordance with any local regulation.

    Guide Energy Solutions, LLC    9330 South Hwy 99   Prague, OK 74864

    For Chemical Emergencies: Call Chemtrec at (800) 424-9300. See SDS (Safety Data Sheet) for further information.

  • Packaging

    Guidenrg1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 70% GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77042-770
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77042-770-013.785 L in 1 JUG; Type 0: Not a Combination Product05/13/2020
    2NDC:77042-770-55208 L in 1 DRUM; Type 0: Not a Combination Product05/13/2020
    3NDC:77042-770-080.237 L in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - Guide Energy Solutions LLC (117045830)