FDA.reportPublic FDA data

Aqua Gel

Manufacturer
AD MEDIOS, S.A. DE C.V. | AD MEDIOS S.A. DE C.V.
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:31

Label at a glance#

ProductAqua Gel
Active ingredientALCOHOL
Label structure21 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#

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

polyacrylic acid (Carbomer), triethanolamine (Trolamine), water

20 L NDC: 77739-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 L NDC: 77739-001-01 AQUAGEL_01AQUAGEL_01

3780 mL NDC: 77739-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_02AQUAGEL_023780 mL NDC: 77739-001-02

1L NDC: 77739-001-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_04AQUAGEL_041L NDC: 77739-001-04

500 mL NDC: 77739-001-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_05AQUAGEL_05500 mL NDC: 77739-001-05

250 mL NDC: 77739-001-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_06AQUAGEL_06250 mL NDC: 77739-001-06

5L NDC: 77739-001-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5L NDC: 77739-001-12

AQUAGEL_07PAQUAGEL_07P

125 mL NDC: 77739-001-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_08AQUAGEL_08125 mL NDC: 77739-001-08

60 mL NDC: 77739-001-09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUAGEL_09AQUAGEL_0960 mL NDC: 77739-001-09

200L NDC: 77739-001-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAQUAGEL_10SAQUAGEL_10200L NDC: 77739-001-10

1000L 77739-001-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000L 77739-001-11 AQUAGEL_11AQUAGEL_11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77739-001-012023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-022023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-042023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-052023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-062023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-082023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-092023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-102023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-112023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487
77739-001-122023-01-30C16284748780-1f386c649-b867-0266-e053-dadaa90a7c1aa619da09-69ea-4679-e053-2a95a90a9487

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77739-001-01Aqua Gel20000 mL in 1 BOTTLEGEL200003
77739-001-02Aqua Gel3780 mL in 1 BOTTLEGEL37803
77739-001-04Aqua Gel1000 mL in 1 BOTTLEGEL10003
77739-001-05Aqua Gel500 mL in 1 BOTTLEGEL5003
77739-001-06Aqua Gel250 mL in 1 BOTTLEGEL2503
77739-001-08Aqua Gel125 mL in 1 BOTTLEGEL1253
77739-001-09Aqua Gel60 mL in 1 BOTTLEGEL603
77739-001-10Aqua Gel200000 mL in 1 CONTAINERGEL2000003
77739-001-11Aqua Gel1000000 mL in 1 CONTAINERGEL10000003
77739-001-12Aqua Gel5000 mL in 1 BOTTLEGEL50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77739-001AQUA GEL (ALCOHOL) GEL [AD MEDIOS, S.A. DE C.V.]3Legacy NDC, 10 package rows20210129_a619da09-69ea-4679-e053-2a95a90a9487.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
77739-00177739-001-01, 77739-001-02, 77739-001-04, 77739-001-05, 77739-001-06, 77739-001-08, 77739-001-09, 77739-001-10, 77739-001-11, 77739-001-12

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
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TROLAMINE9O3K93S3TKIACT
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
b9cf6c77-85dc-62d9-e053-2995a90abe32a619da09-69ea-4679-e053-2a95a90a94872021-01-26WarningsExact identifier
spl id: b9cf6c77-85dc-62d9-e053-2995a90abe32
spl set id: a619da09-69ea-4679-e053-2a95a90a9487

Reported adverse events (FAERS/openFDA)#

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