Umbiliclean

Manufacturer
Advanced Generic Corporation
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:00:15

Label at a glance#

ProductUmbiliclean
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (by volume)

Isopropyl Alcohol (90% conc.)

OTC - PURPOSE SECTION

Purpose

First Aid Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • First Aid to help prevent the risk of infection in minor cuts, scrapes and burns

WARNINGS SECTION

Warnings
For external use only

  • Flammable, keep away from fire or flame
  • If taken internally serious gastric disturbances will occur

Ask doctor before use if you have

  • Deep or puncture wounds, animal bites or serious burns

When using this product

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than one week unless directed by doctor

Stop use and ask a doctor if condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of ingestions, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean affected area
  • apply small amount of this product on the are 1-3 times daily
  • if bandaged, let dry first
  • may be covered with a sterile bandage

INACTIVE INGREDIENT SECTION

Inactive ingredients anise oil, FD&C Green #3, and purified water

OTC - QUESTIONS SECTION

Questions or comments? Contact us at (305) 403-3788 Monday to Friday 9:00AM - 5:00PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

umbilicleanumbiliclean

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-702-042020-12-23C16284748780-19d75b9d0-6031-f424-e053-dadaa90a57ce8eeef2f6-2da5-4936-857e-db777215a83b
45737-702-042020-01-31C16284748780-19d75b9d0-6031-f424-e053-dadaa90a57ce8eeef2f6-2da5-4936-857e-db777215a83b

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
45737-70245737-702-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
7bc6d042-054e-4d5b-9bcc-b85040775f068eeef2f6-2da5-4936-857e-db777215a83b2023-12-27WarningsExact identifier
spl set id: 8eeef2f6-2da5-4936-857e-db777215a83b

Reported adverse events (FAERS/openFDA)#

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