FDA.reportPublic FDA data

70% Advanced Alcohol Gel Sanitizer IV

Manufacturer
Betco Corporation, LTD | RealChem Manufacturing Inc
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:17:01

Label at a glance#

Product70% Advanced Alcohol Gel Sanitizer IV
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available.

Dosage and administration

Read the entire label before using this product. Place enough product on your palm to thoroughly cover your hands. Rub hands together briskly for 30 seconds until dry.

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to reduce microorganisms on the skin.
Use this product when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
• Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours,
consult a physician. • KEEP OUT OF REACH OF CHILDREN.
• If swallowed, get medical help or contact a Poison Control Center right away.

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

Read the entire label before using this product.

Place enough product on your palm to thoroughly cover your hands.
Rub hands together briskly for 30 seconds until dry.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Glycerin, Fragrance (Parfum).

Questions?

OTC - QUESTIONS SECTION

888-GO BETCO (888-462-3826)

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

721E9-00721E9-00

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-100-032024-11-20C16284748780-1d6a99b39-7a89-a426-e053-dadaa90af4c270% Advanced Alcohol Gel Sanitizer IV
65601-100-032022-01-28C16284748780-1d6a99b39-7a89-a426-e053-dadaa90af4c270% Advanced Alcohol Gel Sanitizer IV

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-10065601-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
GLYCERINPDC6A3C0OXIACT
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
275b707f-d82c-f495-e063-6394a90ad72cadc941f8-5ce8-176d-e053-2995a90af3082024-11-20WarningsExact identifier
spl set id: adc941f8-5ce8-176d-e053-2995a90af308

Reported adverse events (FAERS/openFDA)#

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