FDA.reportPublic FDA data

Simply Safe Hand Sanitizer

Manufacturer
CMM CAPITAL, LLC
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:38

Label at a glance#

ProductSimply Safe Hand 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 (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. Water (18.85% v/v).
  3. Glycerin (0.4% v/v).
  4. Hydroxypropyl Cellulose (0.75% v/v).
  5. Hydroxypropyl MethylCellulose (0.75% v/v).

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

Ethyl 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, water, hydroxypropyl cellulose, hydroxypropyl methylcellulose

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL NDC: 79661-001-04 118 ml label118 ml label 3.79L NDC: 79661-001-013.79L NDC: 79661-001-01 946mL NDC: 79661-001-32946mL NDC: 79661-001-32 591mL NDC: 79661-001-20591mL NDC: 79661-001-20 295mL NDC: 79661-001-10295mL NDC: 79661-001-10 236ml NDC:79661-001-08236ml NDC:79661-001-08 59mL NDC: 79661-001-0259mL NDC: 79661-001-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79661-001-012022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-022022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-042022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-082022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-102022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-202022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer
79661-001-322022-01-28C16284748780-1d6a99b39-474f-a426-e053-dadaa90af4c2CMM Capital, LLC Simply Safe Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79661-001-01Simply Safe Hand Sanitizer3785 mL in 1 BOTTLE, DISPENSINGGEL37852
79661-001-02Simply Safe Hand Sanitizer60 mL in 1 BOTTLE, DISPENSINGGEL602
79661-001-04Simply Safe Hand Sanitizer120 mL in 1 BOTTLE, DISPENSINGGEL1202
79661-001-08Simply Safe Hand Sanitizer240 mL in 1 BOTTLE, DISPENSINGGEL2402
79661-001-10Simply Safe Hand Sanitizer300 mL in 1 BOTTLE, DISPENSINGGEL3002
79661-001-20Simply Safe Hand Sanitizer600 mL in 1 BOTTLE, DISPENSINGGEL6002
79661-001-32Simply Safe Hand Sanitizer960 mL in 1 BOTTLE, DISPENSINGGEL9602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79661-001SIMPLY SAFE HAND SANITIZER (ALCOHOL) GEL [CMM CAPITAL, LLC]2Legacy NDC, 7 package rows20200918_aa9607f1-29e2-609b-e053-2995a90ae657.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79661-00179661-001-04, 79661-001-08, 79661-001-02, 79661-001-10, 79661-001-20, 79661-001-32, 79661-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT

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
ad3d6735-d404-3fed-e053-2995a90a7d36aa9607f1-29e2-609b-e053-2995a90ae6572020-08-19WarningsExact identifier
spl id: ad3d6735-d404-3fed-e053-2995a90a7d36
spl set id: aa9607f1-29e2-609b-e053-2995a90ae657

Reported adverse events (FAERS/openFDA)#

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