FDA.reportPublic FDA data

Antibacterial Gel

Manufacturer
Evolve Verde, S.A. de C.V.
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:38

Label at a glance#

ProductAntibacterial Gel
Active ingredientALCOHOL
Label structure9 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

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol Antiseptic 70%

Purpose

OTC - PURPOSE SECTION

   Antiseptic

Use[s]

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, Triethanolamine, Propylene Glycol, Aloe Vera extract, Carbomer and water bidistilled

Package Labeling: (78157-000-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: (78157-000-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: (78157-000-03)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78157-000-012022-01-28C16284748780-1d6a99b39-cf82-a426-e053-dadaa90af4c2Antibacterial Gel
78157-000-022022-01-28C16284748780-1d6a99b39-cf82-a426-e053-dadaa90af4c2Antibacterial Gel
78157-000-032022-01-28C16284748780-1d6a99b39-cf82-a426-e053-dadaa90af4c2Antibacterial Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78157-000-01Antibacterial Gel3785.41 mL in 1 BOTTLEGEL3785.411
78157-000-02Antibacterial Gel208198 mL in 1 DRUMGEL2081981
78157-000-03Antibacterial Gel1040000 mL in 1 TANKGEL10400001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78157-000ANTIBACTERIAL GEL (ALCOHOL) GEL [EVOLVE VERDE, S.A. DE C.V.]1Legacy NDC, 3 package rows20200527_12bed13b-97fa-41f5-ac35-bda40af96e48.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78157-00078157-000-01, 78157-000-02, 78157-000-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
a68a8e14-5747-d9d9-e053-2a95a90a200b12bed13b-97fa-41f5-ac35-bda40af96e482020-05-26WarningsExact identifier
spl id: a68a8e14-5747-d9d9-e053-2a95a90a200b
spl set id: 12bed13b-97fa-41f5-ac35-bda40af96e48

Reported adverse events (FAERS/openFDA)#

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