SCI 70 Hand Sanitizer Gel

Manufacturer
Southern Chem Industries LLC
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:50

Label at a glance#

ProductSCI 70 Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor some fabrics. Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Carbomer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin - Recommended for repeated use.

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 occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center immediately.

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

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, carbomer, and purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package.Label Principal Display PanelPackage.Label Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55549-014-01SCI 70 Hand Sanitizer Gel3785 mL in 1 BOTTLEGEL37851
55549-014-02SCI 70 Hand Sanitizer Gel74 mL in 1 PACKETGEL741
55549-014-05SCI 70 Hand Sanitizer Gel18927 mL in 1 PAILGEL189271
55549-014-25SCI 70 Hand Sanitizer Gel946353 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL9463531
55549-014-30SCI 70 Hand Sanitizer Gel1135500 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL11355001
55549-014-32SCI 70 Hand Sanitizer Gel946 mL in 1 BOTTLEGEL9461
55549-014-55SCI 70 Hand Sanitizer Gel208198 mL in 1 DRUMGEL2081981
55549-014-64SCI 70 Hand Sanitizer Gel1892 mL in 1 BOTTLEGEL18921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55549-014SCI 70 HAND SANITIZER GEL (ALCOHOL) GEL [SOUTHERN CHEM INDUSTRIES LLC]1Legacy NDC, 8 package rows20201002_b0a3263a-e282-afc0-e053-2995a90a29e0.zip

Products#

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

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

NDC Codes#

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
b0a3219c-108b-6361-e053-2a95a90a893fb0a3263a-e282-afc0-e053-2995a90a29e02020-10-01WarningsExact identifier
spl id: b0a3219c-108b-6361-e053-2a95a90a893f
spl set id: b0a3263a-e282-afc0-e053-2995a90a29e0

Reported adverse events (FAERS/openFDA)#

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