FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
REALCHEM MANUFACTURING
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:37:19

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
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 hand sanitizer unscented gel manufactured according to FDA Guidance.

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

glycerin, RapidGel EZ1, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml NDC: 79363-701-04

CHD 4oz Unscented Gel Hand SanitizerCHD 4oz Unscented Gel Hand Sanitizer

237 ml NDC: 79363-701-08

8 oz Unscented 70% Driftless Life8 oz Unscented 70% Driftless Life

ProtectRXX 70% Gel 8 oz UnscentedProtectRXX 70% Gel 8 oz Unscented

LifesGuard 70% UnScented Gel 8 ozLifesGuard 70% UnScented Gel 8 oz

473 ml NDC: 79363-701-16 LifesGuard 70% UnScented Gel 16 ozLifesGuard 70% UnScented Gel 16 oz

946 ml NDC:79363-701-32

32 oz Driftless Life 70% Unscented32 oz Driftless Life 70% Unscented

LifesGuard 70% UnScented Gel 32 ozLifesGuard 70% UnScented Gel 32 oz

3785 mL NDC: 79363-701-28

1 Gal Driftless Life 70% Unscented1 Gal Driftless Life 70% Unscented

LifesGuard 70% UnScented Gel 1 GalLifesGuard 70% UnScented Gel 1 Gal

ProtectRxx 70% Gel 1 Gallon UnscentedProtectRxx 70% Gel 1 Gallon Unscented

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN7
581662ethanol 0.7 ML/ML Topical GelSCD7
581662ethanol 70 % Topical GelSY7
581662ethyl alcohol 70 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79363-701-042022-07-29C16284748780-1e4f33bdf-acc4-d8a0-e053-dadaa90a6e4eaca059a2-99a7-8dd4-e053-2995a90ac80a
79363-701-082022-07-29C16284748780-1e4f33bdf-acc4-d8a0-e053-dadaa90a6e4eaca059a2-99a7-8dd4-e053-2995a90ac80a
79363-701-162022-07-29C16284748780-1e4f33bdf-acc4-d8a0-e053-dadaa90a6e4eaca059a2-99a7-8dd4-e053-2995a90ac80a
79363-701-282022-07-29C16284748780-1e4f33bdf-acc4-d8a0-e053-dadaa90a6e4eaca059a2-99a7-8dd4-e053-2995a90ac80a
79363-701-322022-07-29C16284748780-1e4f33bdf-acc4-d8a0-e053-dadaa90a6e4eaca059a2-99a7-8dd4-e053-2995a90ac80a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79363-701-04Hand Sanitizer118 mL in 1 BOTTLEGEL1187
79363-701-08Hand Sanitizer237 mL in 1 BOTTLEGEL2377
79363-701-16Hand Sanitizer473 mL in 1 BOTTLEGEL4737
79363-701-28Hand Sanitizer3785 mL in 1 BOTTLEGEL37857
79363-701-32Hand Sanitizer946 mL in 1 BOTTLEGEL9467

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79363-701HAND SANITIZER (ALCOHOL) GEL [REALCHEM MANUFACTURING]7Legacy NDC, 5 package rows20210127_aca059a2-99a7-8dd4-e053-2995a90ac80a.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
79363-70179363-701-28, 79363-701-08, 79363-701-16, 79363-701-32, 79363-701-04

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
GLYCERINPDC6A3C0OXIACT
RAPIDGEL EZ133JH4A7R2KIACT
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
b9c21d5f-ef3a-1ab8-e053-2a95a90a99b9aca059a2-99a7-8dd4-e053-2995a90ac80a2021-01-25WarningsExact identifier
spl id: b9c21d5f-ef3a-1ab8-e053-2a95a90a99b9
spl set id: aca059a2-99a7-8dd4-e053-2995a90ac80a

Reported adverse events (FAERS/openFDA)#

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