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 Gel
- Manufacturer
- Higley Industries, Inc.
- Effective date
- 2020-03-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:04:19
Label at a glance#
ProductAntiseptic Hand Sanitizer Gel
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° (59-86°F) • super 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
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
- 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° (59-86°F)
• super avoid freezing and excessive heat above 40°C (104°F)
• do not reuse container. Dispose of properly
Inactive ingredients
Water, Glycerol, Ammonium acryloyldimethyltaurate, 2-carboxyethyl acrylate crosspolymer
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
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 |
|---|---|---|---|---|---|
| 65584-100-12 | 2023-01-30 | C162847 | 48780-1 | f386c649-ba9f-0266-e053-dadaa90a7c1a | Antiseptic HAND SANITIZER gel |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Antiseptic Hand Sanitizer Gel
- Ethyl Alcohol
- ALCOHOL
- WATER
- GLYCERIN
- AMMONIUM ACRYLOYLDIMETHYLTAURATE
- 2-CARBOXYETHYL ACRYLATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65584-100 | 65584-100-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| AMMONIUM ACRYLOYLDIMETHYLTAURATE | KBC00G95HI | IACT |
| 2-CARBOXYETHYL ACRYLATE | KM1E1216WR | 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 |
|---|---|---|---|---|---|---|
| decb81b3-736f-4001-a185-3da010637c57 | 2fa47aa7-3918-4af2-a598-230c14eaab9a | 2020-03-23 | Warnings | decb81b3-736f-4001-a185-3da010637c57 2fa47aa7-3918-4af2-a598-230c14eaab9a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.