FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Capace Medical, S.A. de C.V. | Mario Hidalgo
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:22

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure23 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 75% 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, carbomer 940, trolamine, aloe vera, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 5 mLLabel 5 mL5 mL NDC: 78096-123-01

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 100 mLLabel 100 mL100 mL NDC: 78096-123-02

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 125 mLLabel 125 mL125 mL NDC: 78096-123-03

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 250 mLLabel 250 mL250 mL NDC: 78096-123-04

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 330 mLLabel 330 mL330 mL NDC: 78096-123-05

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 500 mLLabel 500 mL

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1000 mLLabel 1000 mL

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 3785 mLLabel 3785 mL3785 mL NDC: 78096-123-08

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20000Label 2000020000 mL NDC: 78096-123-09

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 200000 mLLabel 200000 mL200000 mL NDC: 78096-123-10

Package label principal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1000000 mLLabel 1000000 mL1000000 mL NDC: 78096-123-11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78096-123-012022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-022022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-032022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-042022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-052022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-062022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-072022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-082022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-092022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-102022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer
78096-123-112022-01-28C16284748780-1d6a99b39-73d9-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78096-123-01Hand Sanitizer5 mL in 1 PACKAGEGEL52
78096-123-02Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1002
78096-123-03Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1252
78096-123-04Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2502
78096-123-05Hand Sanitizer330 mL in 1 BOTTLE, PLASTICGEL3302
78096-123-06Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5002
78096-123-07Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10002
78096-123-08Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37852
78096-123-09Hand Sanitizer20000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL200002
78096-123-10Hand Sanitizer200000 mL in 1 DRUMGEL2000002
78096-123-11Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78096-123HAND SANITIZER (ALCOHOL) GEL [CAPACE MEDICAL, S.A. DE C.V.]2Legacy NDC, 11 package rows20200607_a6c2b4a7-832b-6d6e-e053-2a95a90a3b60.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
78096-12378096-123-01, 78096-123-02, 78096-123-03, 78096-123-04, 78096-123-05, 78096-123-06, 78096-123-07, 78096-123-08, 78096-123-09, 78096-123-10, 78096-123-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
a75b6e0d-a68d-065b-e053-2a95a90a93a8a6c2b4a7-832b-6d6e-e053-2a95a90a3b602020-06-05WarningsExact identifier
spl id: a75b6e0d-a68d-065b-e053-2a95a90a93a8
spl set id: a6c2b4a7-832b-6d6e-e053-2a95a90a3b60

Reported adverse events (FAERS/openFDA)#

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