FDA.reportPublic FDA data

Alcohol Antiseptic Topical Solution

Manufacturer
Chattem, Inc.
Effective date
2020-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:18:09

Label at a glance#

ProductAlcohol Antiseptic 80 Percent Topical
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

■ Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not     available. ■ Healthcare personnel hand rub to help reduce bacteria that potentially can cause disease.

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer Non-sterile Solution

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not 

   available.

■ Healthcare personnel hand rub to help reduce bacteria that potentially can cause disease.

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

When using this product  

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  

OTC - STOP USE SECTION

irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-Sterile Solution
4.2 FL OZ (124 mL)

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution 4.2 FL OZ (124 mL)Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution 4.2 FL OZ (124 mL)

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
41167-470041167-4700-0

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
5c15d81b-a347-4ecb-b57f-c3041c608a9df0664eeb-92e7-4709-9c7b-c9ddded0c2e52022-04-11WarningsExact identifier
spl set id: f0664eeb-92e7-4709-9c7b-c9ddded0c2e5

Reported adverse events (FAERS/openFDA)#

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