70% EtOH Gel w/Vit E Scented

Manufacturer
REALCHEM MANUFACTURING
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
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 scented gel with added Vitamin E manufactured according to the 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 EZ100, Tocopheryl Acetate, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL NDC: 79363-703-08

Simpli_Safe_Cucumber Aloe with Vit E 8ozSimpli_Safe_Cucumber Aloe with Vit E 8oz

Simpli_Safe_Ginger Citrus with Vit E 8ozSimpli_Safe_Ginger Citrus with Vit E 8oz

Simpli_Safe_Lavender with Vit E 8ozSimpli_Safe_Lavender with Vit E 8oz

Simpli_Safe_Lemongrass with Vit E 8ozSimpli_Safe_Lemongrass with Vit E 8oz

Simpli_Safe_LimeSeaSalt with Vit E 8ozSimpli_Safe_LimeSeaSalt with Vit E 8oz

Simpli_Safe_Plumeria with Vit E 70% Gel 8ozSimpli_Safe_Plumeria with Vit E 70% Gel 8oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79363-703-082022-07-29C16284748780-1e4f33bdf-afa8-d8a0-e053-dadaa90a6e4e70% EtOH Gel w/Vit E Scented

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79363-703-08Hand Sanitizer237 mL in 1 BOTTLEGEL2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79363-703HAND SANITIZER (ALCOHOL) GEL [REALCHEM MANUFACTURING]2Legacy NDC, 1 package rows20210127_af0b9cbe-3cc6-e387-e053-2a95a90a82ca.zip

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
79363-70379363-703-08

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
b9c27cd4-12cf-1381-e053-2a95a90a446eaf0b9cbe-3cc6-e387-e053-2a95a90a82ca2021-01-25WarningsExact identifier
spl id: b9c27cd4-12cf-1381-e053-2a95a90a446e
spl set id: af0b9cbe-3cc6-e387-e053-2a95a90a82ca

Reported adverse events (FAERS/openFDA)#

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