Simply 62 Hand Sanitizer Gel

Manufacturer
Froggy's Fog LLC
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:30:54

Label at a glance#

ProductSimply 62 Hand Sanitizer Gel
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 (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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

glycerin, hydrogen peroxide, purified water USP

Simply 62 Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946352.946 mL NDC: 75682-332-25 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel1892 mL NDC: 75682-332-64 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel946 mL NDC: 75682-332-32 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel473 mL NDC: 75682-332-16 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel236.588mL NDC: 75682-332-08 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel118.294mL NDC: 75682-332-04 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel3785.412mL NDC: 75682-332-02 Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel Simply 62 Hand Sanitizer GelSimply 62 Hand Sanitizer Gel1000 mL NDC: 75682-332-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN5
581660ethanol 0.62 ML/ML Topical GelSCD5
581660ethanol 62 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75682-332-01Simply 62 Hand Sanitizer Gel1000 mL in 1 BOTTLE, PUMPGEL10005
75682-332-02Simply 62 Hand Sanitizer Gel3785.412 mL in 1 JUGGEL3785.4125
75682-332-04Simply 62 Hand Sanitizer Gel118.294 mL in 1 BOTTLE, PUMPGEL118.2945
75682-332-08Simply 62 Hand Sanitizer Gel236.588 mL in 1 BOTTLE, PUMPGEL236.5885
75682-332-16Simply 62 Hand Sanitizer Gel473 mL in 1 BOTTLE, PUMPGEL4735
75682-332-25Simply 62 Hand Sanitizer Gel946352.946 mL in 1 TANKGEL946352.9465
75682-332-32Simply 62 Hand Sanitizer Gel946 mL in 1 BOTTLE, PUMPGEL9465
75682-332-64Simply 62 Hand Sanitizer Gel1892 mL in 1 BOTTLE, PUMPGEL18925

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75682-332SIMPLY 62 HAND SANITIZER GEL (ALCOHOL) GEL [FROGGY'S FOG LLC]5Legacy NDC, 8 package rows20201003_adca1402-37a0-0a3c-e053-2995a90a9ebd.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
b0b1c225-c30d-a34b-e053-2a95a90a0b3aadca1402-37a0-0a3c-e053-2995a90a9ebd2020-10-02WarningsExact identifier
spl id: b0b1c225-c30d-a34b-e053-2a95a90a0b3a
spl set id: adca1402-37a0-0a3c-e053-2995a90a9ebd

Reported adverse events (FAERS/openFDA)#

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