FDA.reportPublic FDA data

Alcohol Antiseptic

Manufacturer
Bausch & Lomb Incorporated | Shandong Bausch & Lomb Freda Pharm. Co., Ltd
Effective date
2020-03-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:38:32

Label at a glance#

ProductAlcohol Antiseptic
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

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#

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.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.
Do not use

  • in children less than 2 months of age
  • on open skin wounds

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

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 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Questions?

SPL UNCLASSIFIED SECTION

Call: 1-800-553-5340

Bausch + Lomb, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA

© 2020 Bausch & Lomb Incorporated or its affiliates

Product of China

3846300

Package/Label Principal Display Panel – Label back

SPL UNCLASSIFIED SECTION

label-back.jpg
label-back.jpg

Package/Label Principal Display Panel Label front -Label back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24208-060-02

BAUSCH + LOMB

Alcohol
Antiseptic 80%
Solution

Hand Sanitizer
Non-sterile Solution

Not for Sale

8 FL OZ (236 mL)

label-front.jpg
label-front.jpg

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
24208-06024208-060-02

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
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
324f63cb-7fa9-448c-8a55-253c3b691c098fbde241-0b55-401e-813f-acee2b08cb2c2020-03-29WarningsExact identifier
spl id: 324f63cb-7fa9-448c-8a55-253c3b691c09
spl set id: 8fbde241-0b55-401e-813f-acee2b08cb2c

Reported adverse events (FAERS/openFDA)#

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