Label: FASTENAL CLEAN CHOICE 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 January 13, 2022

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerin (0.63% v/v).
    3. Carbomer 940 (6.27% v/v)
    4. PEG-8 Dimethicone (0.45% v/v)
    5. Trolamine (0.22% v/v)
    6. East Indian Lemon Grass Oil (0.14% v/v)
    7. Purified Water

    The firm does not add other active or inactive ingredients.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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

    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.

  • STOP USE

    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

    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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Carbomer 940, Fragrance, Glycerin, Peg-8 Dimethicone, Trolamine, Water

  • Package Label - Principal Display Panel

    1 Gallon NDC: 74793-0010-6354 ml NDC: 74793-0010-42 L NDC: 74793-0010-5 2 L NDC: 74793-0010-5118 ml NDC: 74793-0010-1236 ml NDC: 74793-0010-2251 ml NDC: 74793-0010-3

  • INGREDIENTS AND APPEARANCE
    FASTENAL CLEAN CHOICE 
    fastenal clean choice gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0010
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.63 mL  in 100 mL
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) 0.14 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 6.27 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.22 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 22.29 mL  in 100 mL
    PEG-8 DIMETHICONE (UNII: GIA7T764OD) 0.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74793-0010-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    2NDC:74793-0010-2236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    3NDC:74793-0010-3251 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    4NDC:74793-0010-4354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    5NDC:74793-0010-52000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/16/2020
    Labeler - Streamline Polymers LLC (117054225)
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