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#
Contacts and useful links#
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-702-04 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-6031-f424-e053-dadaa90a57ce | 8eeef2f6-2da5-4936-857e-db777215a83b |
| 45737-702-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6031-f424-e053-dadaa90a57ce | 8eeef2f6-2da5-4936-857e-db777215a83b |
Products#
Every source-derived product name is available through these pages.
- Umbiliclean
- Isopropyl Alcohol
- ANISE OIL
- FD&C GREEN NO. 3
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-702 | 45737-702-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| ANISE OIL | 6Y89129C8H | IACT |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7bc6d042-054e-4d5b-9bcc-b85040775f06 | 8eeef2f6-2da5-4936-857e-db777215a83b | 2023-12-27 | Warnings | 8eeef2f6-2da5-4936-857e-db777215a83b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
