PureGel Hand Sanitizer Gel

Manufacturer
XMA Servicios de Manufactura S de RL de CV
Effective date
2020-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:14

Label at a glance#

ProductPureGel Hand Sanitizer Gel
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

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 Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020).

The hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product, with percentages iof the active ingredient consistent with the above mentioned final rule, Isopropyl Alcohol (70%, v/v).

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

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.

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.

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.

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

glycerin, purified water USP, carbomer, trolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml NDC: 78108-1705-1 Product Label Front and Back Hand Sanitizer gel 60 mlProduct Label Front and Back Hand Sanitizer gel 60 ml330 ml NDC: 78108-1705-3 Product Label front and back Purgel Hand Sanitizer Gel 330 mlProduct Label front and back Purgel Hand Sanitizer Gel 330 ml1 L NDC: 78108-1705-5 Product Label front and back Puregel Hand Sanitizer Gel 1 LiterProduct Label front and back Puregel Hand Sanitizer Gel 1 Liter1 Gallon NDC: 78108-1705-8 Product Label front and back Puregel Hand Sanitizer Gel 1 GallonProduct Label front and back Puregel Hand Sanitizer Gel 1 Gallon

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78108-170578108-1705-1, 78108-1705-3, 78108-1705-5, 78108-1705-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
28f04490-586c-2a54-e063-6394a90a5101ad1e3d7f-c126-1580-e053-2995a90adbb62024-12-10WarningsExact identifier
spl set id: ad1e3d7f-c126-1580-e053-2995a90adbb6

Reported adverse events (FAERS/openFDA)#

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