FDA.reportPublic FDA data

Fastenal Clean Choice

Manufacturer
Streamline Polymers LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:46:50

Label at a glance#

ProductFastenal Clean Choice
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 Gallon NDC: 74793-0010-61 Gallon NDC: 74793-0010-6354 ml NDC: 74793-0010-4354 ml NDC: 74793-0010-42 L NDC: 74793-0010-5 2 L NDC: 74793-0010-52 L NDC: 74793-0010-5118 ml NDC: 74793-0010-1118 ml NDC: 74793-0010-1236 ml NDC: 74793-0010-2236 ml NDC: 74793-0010-2251 ml NDC: 74793-0010-3251 ml NDC: 74793-0010-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74793-0010-12023-07-28C16284748780-10191ceaa-6497-198a-e063-dbdaa90aec3eFastenal Clean Choice
74793-0010-22023-07-28C16284748780-10191ceaa-6497-198a-e063-dbdaa90aec3eFastenal Clean Choice
74793-0010-32023-07-28C16284748780-10191ceaa-6497-198a-e063-dbdaa90aec3eFastenal Clean Choice
74793-0010-42023-07-28C16284748780-10191ceaa-6497-198a-e063-dbdaa90aec3eFastenal Clean Choice
74793-0010-52023-07-28C16284748780-10191ceaa-6497-198a-e063-dbdaa90aec3eFastenal Clean Choice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74793-0010-1Fastenal Clean Choice118 mL in 1 BOTTLEGEL1184
74793-0010-2Fastenal Clean Choice236 mL in 1 BOTTLEGEL2364
74793-0010-3Fastenal Clean Choice251 mL in 1 BOTTLEGEL2514
74793-0010-4Fastenal Clean Choice354 mL in 1 BOTTLEGEL3544
74793-0010-5Fastenal Clean Choice2000 mL in 1 BOTTLEGEL20004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74793-0010FASTENAL CLEAN CHOICE GEL [STREAMLINE POLYMERS LLC]4Legacy NDC, 5 package rows20220114_b1cc93a6-9644-5b44-e053-2995a90a3004.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74793-001074793-0010-1, 74793-0010-2, 74793-0010-3, 74793-0010-4, 74793-0010-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
EAST INDIAN LEMONGRASS OILUP0M8M3VZWIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57b0b4f-2962-b459-e053-2a95a90a7479b1cc93a6-9644-5b44-e053-2995a90a30042022-01-13WarningsExact identifier
spl id: d57b0b4f-2962-b459-e053-2a95a90a7479
spl set id: b1cc93a6-9644-5b44-e053-2995a90a3004

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.