FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
ACE CHEM SOLUTIONS | ACE Soluciones Quimicas de Monterrey SAS de CV
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:34:42

Label at a glance#

ProductHand Sanitizer ACE-GA001
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) (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. Carbomer 940 (0.20% v/v).
  3. Triethanolamine hydriodide (1.00% 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 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, triethanolamine hydriodide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1200000 ml NDC: 77308-002-13

1200000 ml.jpg1200000 ml.jpg

200000 ml NDC: 77308-002-12

200000 ml.jpg200000 ml.jpg

20000 ml NDC: 77308-002-11

20000 ml.jpg20000 ml.jpg

4000 ml NDC: 77308-002-24

4000 ml.jpg4000 ml.jpg

1000 ml NDC: 77308-002-23

1000 ml.jpg1000 ml.jpg

500 ml NDC: 77308-002-22

500 ml.jpg500 ml.jpg

250 ml NDC: 77308-002-21

250 ml.jpg250 ml.jpg

2 ml NDC: 77308-002-25

2 ml2 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77308-002-112022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-122022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-132022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-212022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-222022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-232022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-242022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23
77308-002-252022-01-28C16284748780-1d6a99b39-e6ea-a426-e053-dadaa90af4c2a496b2fe-fcf5-41cf-e053-2a95a90a0c23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77308-002-11Hand SanitizerACE-GA00120 L in 1 JUGGEL206
77308-002-12Hand SanitizerACE-GA001200 L in 1 DRUMGEL2006
77308-002-13Hand SanitizerACE-GA0011200 L in 1 CONTAINERGEL12006
77308-002-21Hand SanitizerACE-GA0010.25 L in 1 BOTTLEGEL0.256
77308-002-22Hand SanitizerACE-GA0010.5 L in 1 BOTTLEGEL0.56
77308-002-23Hand SanitizerACE-GA0011 L in 1 BOTTLEGEL16
77308-002-24Hand SanitizerACE-GA0014 L in 1 BOTTLEGEL46
77308-002-25Hand SanitizerACE-GA0010.002 L in 1 DOSE PACKGEL0.0026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77308-002HAND SANITIZER ACE-GA001 (ALCOHOL) GEL [ACE CHEM SOLUTIONS]6Legacy NDC, 8 package rows20201208_a496b2fe-fcf5-41cf-e053-2a95a90a0c23.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77308-00277308-002-11, 77308-002-12, 77308-002-13, 77308-002-21, 77308-002-22, 77308-002-23, 77308-002-24, 77308-002-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT
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
b5e2ff4c-8f68-4006-e053-2a95a90ab89ba496b2fe-fcf5-41cf-e053-2a95a90a0c232020-12-07WarningsExact identifier
spl id: b5e2ff4c-8f68-4006-e053-2a95a90ab89b
spl set id: a496b2fe-fcf5-41cf-e053-2a95a90a0c23

Reported adverse events (FAERS/openFDA)#

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