FDA.reportPublic FDA data

ClearSolv Hand Sanitizing Gel

Manufacturer
ClearSolv Solvents USA Inc. | Jason Broome
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:17

Label at a glance#

ProductClearSolv Hand Sanitizing Gel
Active ingredientALCOHOL
Label structure13 sections

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:

a. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.0% v/v).

c. Carbopol 940 (0.40% v/v).

d. Aminomethyl proponol (0.1% v/v)

d. 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.

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

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.

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.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

glycerin, carbopol 940, aminomethyl proponol, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

000 ml NDC: 90091-001-00

Front PackageFront PackageBack PackageBack Package

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90091-001-392022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-492022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-592022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-692022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-792022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-892022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer
90091-001-992022-01-28C16284748780-1d6a99b39-5f39-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90091-001-39ClearSolv Hand Sanitizing Gel59 mL in 1 BOTTLEGEL591
90091-001-49ClearSolv Hand Sanitizing Gel118 mL in 1 BOTTLEGEL1181
90091-001-59ClearSolv Hand Sanitizing Gel500 mL in 1 BOTTLEGEL5001
90091-001-69ClearSolv Hand Sanitizing Gel1000 mL in 1 BOTTLEGEL10001
90091-001-79ClearSolv Hand Sanitizing Gel3780 mL in 1 BOTTLEGEL37801
90091-001-89ClearSolv Hand Sanitizing Gel208000 mL in 1 DRUMGEL2080001
90091-001-99ClearSolv Hand Sanitizing Gel1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90091-001CLEARSOLV HAND SANITIZING GEL (ETHYL ALCOHOL) GEL [CLEARSOLV SOLVENTS USA INC.]1Legacy NDC, 7 package rows20200811_ab9c7255-ca00-3812-e053-2a95a90aee0c.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90091-00190091-001-99, 90091-001-89, 90091-001-79, 90091-001-69, 90091-001-59, 90091-001-49, 90091-001-39

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
CARBOMER 9404Q93RCW27EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
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
ab9c7255-ca01-3812-e053-2a95a90aee0cab9c7255-ca00-3812-e053-2a95a90aee0c2020-07-29WarningsExact identifier
spl id: ab9c7255-ca01-3812-e053-2a95a90aee0c
spl set id: ab9c7255-ca00-3812-e053-2a95a90aee0c

Reported adverse events (FAERS/openFDA)#

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