FDA.reportPublic FDA data

Foaming Hand Sanitizing Rub

Manufacturer
Horizon Chemical Co Inc
Effective date
2020-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:17

Label at a glance#

ProductFoaming Hand Sanitizing Rub
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 66% 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

PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER, 2-(PERFLUOROHEXYL)ETHANOL, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 79712-200-01

Foaming Hand SanitizerFoaming Hand Sanitizer

Foaming Hand Sanitizer 5glFoaming Hand Sanitizer 5gl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2388174ethanol 66 % Topical FoamPSN2
2388174ethanol 0.66 ML/ML Topical FoamSCD2
2388174ethanol 66 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79712-200-012022-01-28C16284748780-1d6a99b39-977b-a426-e053-dadaa90af4c2ab95442b-9a0c-ecd5-e053-2a95a90a8007
79712-200-022022-01-28C16284748780-1d6a99b39-977b-a426-e053-dadaa90af4c2ab95442b-9a0c-ecd5-e053-2a95a90a8007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79712-200-01Foaming Hand Sanitizing Rub3785 mL in 1 JUGLIQUID37852
79712-200-02Foaming Hand Sanitizing Rub18927 mL in 1 PAILLIQUID189272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79712-200FOAMING HAND SANITIZING RUB (ALCOHOL) LIQUID [HORIZON CHEMICAL CO INC]2Legacy NDC, 2 package rows20201023_ab95442b-9a0c-ecd5-e053-2a95a90a8007.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
79712-20079712-200-01, 79712-200-02

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMERD76Z87928NIACT
2-(PERFLUOROHEXYL)ETHANOLG2R5YO5N3VIACT

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
b24428a8-0a3c-fe72-e053-2a95a90a9b36ab95442b-9a0c-ecd5-e053-2a95a90a80072020-10-22WarningsExact identifier
spl id: b24428a8-0a3c-fe72-e053-2a95a90a9b36
spl set id: ab95442b-9a0c-ecd5-e053-2a95a90a8007

Reported adverse events (FAERS/openFDA)#

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