EZ Gel 12 Aloe

Manufacturer
BRENNTAG MID-SOUTH, INC.
Effective date
2023-09-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:25:50

Label at a glance#

ProductEZ Gel 12 Aloe
Active ingredientALCOHOL
Label structure12 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

Active Ingredient (s)Active Ingredient (s)

Purpose

OTC - PURPOSE SECTION

AntisepticAntisepticAntiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potenially 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

Stop use and ask doctor

OTC - STOP USE SECTION

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.

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

STORAGE AND HANDLING SECTION

• Store between 15-30C (59-86F)

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

RECENT MAJOR CHANGES SECTION

Note: Recent Major Changes (§ 201.57(a)(5))



When substantive labeling changes have been made to any of the following sections of the FPI within the preceding 12 months, the heading(s) of the changed section(s) must be listed in Highlights under the heading Recent Major Changes (§ 201.57(a)(5)):

• Boxed Warning

• Indications and Usage

• Dosage and Administration

• Contraindications

• Warnings and Precautions



Changes that must not be listed in Recent Major Changes include:

• Changes to sections other than the five listed above

• Changes that are not substantive (i.e., minor revisions such as correcting typographical errors or grammatical changes)

• Changes resulting from converting to the PLR format alone



a. What must be included ?

Each listing must include the section heading, the subsection heading (if appropriate), identifying number of the corresponding changed section or subsection, and the date on which the change was incorporated in the labeling (i.e., date the supplement was approved) in month/year format (e.g., 6/2010 or Jun 2010) (§ 201.57(a)(5)).

Product Name

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EZ Gel 12 AloeEZ Gel 12 Aloe

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
65353-526265353-5262-1

Ingredients#

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

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

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
05f7269d-46ba-b917-e063-6294a90acf76bbbad572-81fb-6a49-e053-2995a90aaad22023-09-22WarningsExact identifier
spl id: 05f7269d-46ba-b917-e063-6294a90acf76
spl set id: bbbad572-81fb-6a49-e053-2995a90aaad2

Reported adverse events (FAERS/openFDA)#

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