FDA.reportPublic FDA data

70% IPA Scented Gel Hand Sanitizer

Manufacturer
RealChem Manufacturing Inc | REALCHEM MANUFACTURING
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:37:19

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 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 scented hand sanitizer gel manufactured with denatured isopropyl alcohol (70% v/v).

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl 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

rapidgel EZ1, fragrance (parfum), purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 ml NDC: 79363-721-08

NexxChem 70% Gel IPA Lemongrass Scented 8 ozNexxChem 70% Gel IPA Lemongrass Scented 8 oz

NexxChem 70% Gel IPA LimeSeaSalt Scented 8 ozNexxChem 70% Gel IPA LimeSeaSalt Scented 8 oz

473ml NDC: 79363-721-16

NexxChem 70% Gel IPA LimeSeaSalt Scented 16 ozNexxChem 70% Gel IPA LimeSeaSalt Scented 16 oz

3785ml NDC: 79363-721-28

NexxChem 70% IPA LimeSeaSalt Gel Hand SanitizerGallonNexxChem 70% IPA LimeSeaSalt Gel Hand SanitizerGallon

LifesGuard 70% Scented Gel LemonGrass1 GalLifesGuard 70% Scented Gel LemonGrass1 Gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79363-721-082022-07-29C16284748780-1e4f33bdf-9f74-d8a0-e053-dadaa90a6e4e70% IPA Scented Gel Hand Sanitizer
79363-721-162022-07-29C16284748780-1e4f33bdf-9f74-d8a0-e053-dadaa90a6e4e70% IPA Scented Gel Hand Sanitizer
79363-721-282022-07-29C16284748780-1e4f33bdf-9f74-d8a0-e053-dadaa90a6e4e70% IPA Scented Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79363-721-08Hand Sanitizer237 mL in 1 BOTTLEGEL2375
79363-721-16Hand Sanitizer473 mL in 1 BOTTLEGEL4735
79363-721-28Hand Sanitizer3785 mL in 1 BOTTLEGEL37855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79363-721HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [REALCHEM MANUFACTURING INC]5Legacy NDC, 3 package rows20210127_b25aa55f-16e7-fcfc-e053-2995a90a3017.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79363-72179363-721-08, 79363-721-16, 79363-721-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
RAPIDGEL EZ133JH4A7R2KIACT

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
b9c1a87d-c0bc-603b-e053-2995a90acaa8b25aa55f-16e7-fcfc-e053-2995a90a30172021-01-25WarningsExact identifier
spl id: b9c1a87d-c0bc-603b-e053-2995a90acaa8
spl set id: b25aa55f-16e7-fcfc-e053-2995a90a3017

Reported adverse events (FAERS/openFDA)#

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