FDA.reportPublic FDA data

Alcohol Antiseptic 75% Topical Solution SFC02

Manufacturer
ChemQuest Chemicals LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:26

Label at a glance#

ProductAntiseptic Hand Rub
Active ingredientALCOHOL
Label structure8 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#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient[s]Purpose
Ethyl Alcohol 75% v/v. Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Rub

Use[s]

INDICATIONS & USAGE SECTION

Health care 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

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.

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

aloe vera, amp ultra 2000, carbopol ultrez 20, fragrance, tocopheryl acetate (vii E), purified water USP, xiameter OFX 190

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77441-100177441-1001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 1342809Y72KV36IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
e68c63f4-c588-1727-e053-2995a90a9adaa8506aff-a2c4-5ecb-e053-2a95a90ada192022-08-18WarningsExact identifier
spl set id: a8506aff-a2c4-5ecb-e053-2a95a90ada19

Reported adverse events (FAERS/openFDA)#

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