FDA.reportPublic FDA data

Multi-Purpose Sanitizing and Cleansing Alcohol Wipes

Manufacturer
Southern Chem Industries LLC
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:24

Label at a glance#

ProductMulti-Purpose Sanitizing and Cleansing Alcohol Wipes
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Wet hands thoroughly with product, and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age whould be supervised when using this product.

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

  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.

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 repeat 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

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. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age whould be supervised when using this product.

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

glycerin, hydrogen peroxide, purified water USP

RECENT MAJOR CHANGES SECTION

Wet hands thoroughly with product, and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age whould be supervised when using this product

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package.Label Principal Display PanelPackage.Label Principal Display PanelPackage.Label Principal Display PanelPackage.Label Principal Display PanelPackage.Label Principal Display PanelPackage.Label Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN1
1489307ethanol 0.7 ML/ML Medicated PadSCD1
1489307ethanol 70 % Medicated PadSY1
1489307ethanol 70 % Medicated WipesSY1
1489307ethyl alcohol 70 % ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55549-010-502022-01-28C16284748780-1d6a99b39-7bf9-a426-e053-dadaa90af4c2Ethyl Alcohol WIpes 70
55549-010-602022-01-28C16284748780-1d6a99b39-7bf9-a426-e053-dadaa90af4c2Ethyl Alcohol WIpes 70
55549-010-802022-01-28C16284748780-1d6a99b39-7bf9-a426-e053-dadaa90af4c2Ethyl Alcohol WIpes 70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55549-010-50Multi-Purpose Sanitizing and Cleansing Alcohol Wipes2500 mL in 1 PAILCLOTH25001
55549-010-60Multi-Purpose Sanitizing and Cleansing Alcohol Wipes800 mL in 1 CANISTERCLOTH8001
55549-010-80Multi-Purpose Sanitizing and Cleansing Alcohol Wipes400 mL in 1 CANISTERCLOTH4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55549-010MULTI-PURPOSE SANITIZING AND CLEANSING ALCOHOL WIPES (ALCOHOL) CLOTH [SOUTHERN CHEM INDUSTRIES LLC]1Legacy NDC, 3 package rows20200929_b061d0f2-03e2-d73f-e053-2a95a90a8a3e.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
55549-01055549-010-80, 55549-010-60, 55549-010-50

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
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b061d6c7-1e79-d5a8-e053-2a95a90ac7fdb061d0f2-03e2-d73f-e053-2a95a90a8a3e2020-09-28WarningsExact identifier
spl id: b061d6c7-1e79-d5a8-e053-2a95a90ac7fd
spl set id: b061d0f2-03e2-d73f-e053-2a95a90a8a3e

Reported adverse events (FAERS/openFDA)#

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