Gel Hand Sanitizer - Carbomer Formula

Manufacturer
Streamline Polymers LLC
Effective date
2021-02-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:38:04

Label at a glance#

ProductHand Sanitizer
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.

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.

  1. Glycerol (0.63% v/v).
  2. Carbomer 940 (6.27% v/v).
  3. PEG-8 Dimethicone (0.45% v/v)
  4. Trolamine (0.22% v/v)
  5. East Indian Lemon Grass Oil (0.14% v/v)
  6. Sterile distilled water or boiled cold water.

The firm does not add other active 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

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74793-0006-774793-0006-7

74793-0006-674793-0006-616.9oz Gel Tall NDC 74793-0006-516.9oz Gel Tall NDC 74793-0006-58.5 oz NDC: 74793-0006-18.5 oz NDC: 74793-0006-116.9 oz NDC: 74793-0006-216.9 oz NDC: 74793-0006-28.5 oz NDC: 74793-0006-1

16.9 oz NDC: 74793-0006-2

1 Gallon NDC: 74793-0006-31 Gallon NDC: 74793-0006-3

8.5 oz Lemon NDA 74793-0006-48.5 oz Lemon NDA 74793-0006-4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74793-0006-1Hand Sanitizer250 mL in 1 BOTTLEGEL2505
74793-0006-2Hand Sanitizer500 mL in 1 BOTTLEGEL5005
74793-0006-3Hand Sanitizer3780 mL in 1 BOTTLEGEL37805
74793-0006-5Hand Sanitizer500 mL in 1 BOTTLEGEL5005
74793-0006-6Hand Sanitizer479 mL in 1 BOTTLEGEL4795
74793-0006-7Hand Sanitizer241 mL in 1 BOTTLEGEL2415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74793-0006HAND SANITIZER (ALCOHOL) GEL [STREAMLINE POLYMERS LLC]5Legacy NDC, 6 package rows20210212_aa71d621-ef78-3cbb-e053-2995a90acc4e.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
74793-000674793-0006-1, 74793-0006-2, 74793-0006-3, 74793-0006-5, 74793-0006-6, 74793-0006-7

Ingredients#

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

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

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
bad9160d-4d05-4525-e053-2995a90a5e99aa71d621-ef78-3cbb-e053-2995a90acc4e2021-02-08WarningsExact identifier
spl id: bad9160d-4d05-4525-e053-2995a90a5e99
spl set id: aa71d621-ef78-3cbb-e053-2995a90acc4e

Reported adverse events (FAERS/openFDA)#

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