Indications and uses
hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available
Antiseptic Hand Sanitizer Foam
- Manufacturer
- Higley Industries, Inc.
- Effective date
- 2020-03-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:04:27
Label at a glance#
ProductAntiseptic Hand Sanitizer Foam
Active ingredientALCOHOL
Label structure10 sections
Dosage and administration
wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing
Storage and handling
store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F) do not reuse container. Dispose of properly
Contacts and useful links#
Websitewww.higleyinc.com
WWW.HIGLEYINC.COM
WWW.HIGLEYINC.COMLabel contents#
Full prescribing information#
Active ingredient
Ethyl Alcohol 62%
Purpose
Antiseptic
Uses
- hand sanitizer to decrease bacteria on the skin
- recommended for repeated use
- for use when soap and water are not available
Warnings
Flammable, keep away from fire/flame
For external use only
Do not use
- in children less than 2 months of age
- on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
- irritation and redness develop
- condition persists for more than 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- wet hands thoroughly with product and allow to dry without wiping
- supervise children under 6 years of age when using this product to avoid swallowing
Other information
- store between 15-30°C (59-86°F)
- avoid freezing and excessive heat above 40°C (104°F)
- do not reuse container. Dispose of properly
Inactive ingredients
Water, Glycerol, PEG-10 Dimethicone
Questions?
+1-800-535-5053
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM
SPL UNCLASSIFIED SECTION
Since H 1923
Antiseptic
HAND SANITIZER
Foam
H Higley
Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003
Packaging
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65584-105-12 | 2023-01-30 | C162847 | 48780-1 | f386c64a-353a-0266-e053-dadaa90a7c1a | Antiseptic Hand Sanitizer Foam |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Antiseptic Hand Sanitizer Foam
- Ethyl alcohol
- ALCOHOL
- WATER
- GLYCERIN
- PEG-10 DIMETHICONE (600 CST)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65584-105 | 65584-105-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEG-10 DIMETHICONE (600 CST) | 8PR7V1SVM0 | 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 |
|---|---|---|---|---|---|---|
| 0335230e-d264-4026-bd8f-2965cbc49766 | ec68ac94-2831-4cff-9627-cb40c54da4d9 | 2020-03-22 | Warnings | 0335230e-d264-4026-bd8f-2965cbc49766 ec68ac94-2831-4cff-9627-cb40c54da4d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.