SCI 80 Hand Sanitizer

Manufacturer
Southern Chem Industries LLC
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:16:21

Label at a glance#

ProductSCI 80 Hand 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 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) (80%, 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.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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 and 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

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 serious condition. Keep out of reach of children. If swallowed, get medical help of 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

  • 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 Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Package.Label Principal Display PanelPackage.Label Principal Display Panelglycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Principal Display PanelPackage Label Principal Display Panel946 mL NDC: 55549-001-32

or

1892 mL NDC: 55549-001-64

or

3785 mL NDC: 55549-001-01

or

118927 mL NDC: 55549-001-05

or

208198 mL NDC: 55549-001-55

or

946353 mL NDC: 55549-001-25

or

1135500 mL NDC: 55549-001-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN4
1039339ethanol 0.8 ML/ML Topical SolutionSCD4
1039339ethanol 80 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55549-001-012022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-052022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-252022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-302022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-322022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-552022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%
55549-001-642022-01-28C16284748780-1d6a99b39-8db7-a426-e053-dadaa90af4c280%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55549-001-01SCI 80 Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37854
55549-001-05SCI 80 Hand Sanitizer18927 mL in 1 BOTTLE, PLASTICLIQUID189274
55549-001-25SCI 80 Hand Sanitizer946353 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID9463534
55549-001-30SCI 80 Hand Sanitizer1135500 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID11355004
55549-001-32SCI 80 Hand Sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9464
55549-001-55SCI 80 Hand Sanitizer208198 mL in 1 DRUMLIQUID2081984
55549-001-64SCI 80 Hand Sanitizer1892 mL in 1 BOTTLE, PLASTICLIQUID18924

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55549-001SCI 80 HAND SANITIZER (ALCOHOL) LIQUID [SOUTHERN CHEM INDUSTRIES LLC]4Legacy NDC, 7 package rows20200607_a36aa584-dfb9-3223-e053-2995a90a9417.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
55549-00155549-001-32, 55549-001-01, 55549-001-05, 55549-001-64, 55549-001-25, 55549-001-30, 55549-001-55

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
a75d1855-434d-7181-e053-2a95a90a817ea36aa584-dfb9-3223-e053-2995a90a94172020-06-05WarningsExact identifier
spl id: a75d1855-434d-7181-e053-2a95a90a817e
spl set id: a36aa584-dfb9-3223-e053-2995a90a9417

Reported adverse events (FAERS/openFDA)#

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