FDA.reportPublic FDA data

First Aid Antiseptic

Manufacturer
REALCHEM MANUFACTURING | RealChem Manufacturing Inc
Effective date
2021-02-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:37:49

Label at a glance#

ProductFirst Aid Antiseptic
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Clean the affected area; apply small amount of product on the area 1 to 3 times daily. 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 first aid antiseptic manufactured according to FDA Guidance.

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

Antiseptic to decrease germs in minor cuts and scrapes and for preparation of skin prior to an injection; 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

  • Clean the affected area; apply small amount of product on the area 1 to 3 times daily.
  • 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

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 ml NDC: 79363-710-16

ProtextRxx 70% IPA 16ozProtextRxx 70% IPA 16oz

LifesGuard 70% IPA 16ozLifesGuard 70% IPA 16oz

Globesafe 70% IPA 16ozGlobesafe 70% IPA 16oz

Eclipse 70% IPA 16ozEclipse 70% IPA 16oz

946 ml NDC: 79363-710-32

ProtextRxx 70% IPA 32ozProtextRxx 70% IPA 32oz

Globesafe 70% IPA 32ozGlobesafe 70% IPA 32oz

LifesGuard 70% IPA 32ozLifesGuard 70% IPA 32oz

Eclipse 70% IPA 32ozEclipse 70% IPA 32oz

237ml NDC: 79363-710-08

ProtextRxx 70% IPA 8ozProtextRxx 70% IPA 8oz

3785ml NDC: 79363-710-28

ProtectRxx 70% IPA 1 GalProtectRxx 70% IPA 1 Gal

Eclipse 70% IPA 1 GalEclipse 70% IPA 1 Gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79363-710-082022-07-29C16284748780-1e4f33bdf-a020-d8a0-e053-dadaa90a6e4e70% IPA Antiseptic
79363-710-162022-07-29C16284748780-1e4f33bdf-a020-d8a0-e053-dadaa90a6e4e70% IPA Antiseptic
79363-710-282022-07-29C16284748780-1e4f33bdf-a020-d8a0-e053-dadaa90a6e4e70% IPA Antiseptic
79363-710-322022-07-29C16284748780-1e4f33bdf-a020-d8a0-e053-dadaa90a6e4e70% IPA Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79363-710-08First Aid Antiseptic237 mL in 1 BOTTLELIQUID2378
79363-710-16First Aid Antiseptic473 mL in 1 BOTTLELIQUID4738
79363-710-28First Aid Antiseptic3785 mL in 1 BOTTLELIQUID37858
79363-710-32First Aid Antiseptic946 mL in 1 BOTTLELIQUID9468

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79363-710FIRST AID ANTISEPTIC (ISOPROPYL ALCOHOL) LIQUID [REALCHEM MANUFACTURING]8Legacy NDC, 4 package rows20210206_ad19c43e-9f28-58c5-e053-2a95a90a0bd8.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79363-71079363-710-16, 79363-710-32, 79363-710-08, 79363-710-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
ba8a9238-17f2-548a-e053-2a95a90ac54bad19c43e-9f28-58c5-e053-2a95a90a0bd82021-02-04WarningsExact identifier
spl id: ba8a9238-17f2-548a-e053-2a95a90ac54b
spl set id: ad19c43e-9f28-58c5-e053-2a95a90a0bd8

Reported adverse events (FAERS/openFDA)#

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