Dosage and administration
• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.
Aurora Fresh Gel
- Manufacturer
- Aurora Specialty Chemistries
- Effective date
- 2022-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:30
Label at a glance#
ProductAurora Fresh Gel
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections
Storage and handling
Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is a gel hand sanitizer with citrus fragrance manufactured according to standard CGMP.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with existing hand sanitizer products sold OTC throughout the United States and Globally:
Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (1.39% v/v).
Carbomer-980 (0.7% v/v).
Isopropyl Myristate (0.07% v/v)
DL-Alpha-Tocopherol Acetate (0.07% v/v)
Trolamine (0.7% v/v)
Citral (0.07% v/v)
Sterile distilled water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(s)
Isopropyl Alcohol 70%
Purpose
Antiseptic / Hand Sanitizer
Use(s)
Hand Sanitizer to help reduce bacteria that potentially cause disease.
For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from flame.
Do Not Use
- In children less than 2 months of age
- On open skin wounds
OTC - WHEN USING SECTION
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may besigns of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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
• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
deionized water, glycerin, trolamine, carbomer, tocopheryl acetate, isopropyl myristate, fragrance
Package Label - Principal Display Panel
5 GAL (18.9 L) NDC: 77807-003-05
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77807-003-05 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6c3d-198a-e063-dbdaa90aec3e | Aurora Fresh Gel Lime Citrus Scented Hand Sanitizer with Vitamin E 5 Gallons (18.9 L) Container |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77807-003-05 | Aurora Fresh Gel | 18927 mL in 1 CONTAINER | GEL | 18927 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aurora Fresh Gel
- Alcohol
- ISOPROPYL ALCOHOL
- WATER
- CARBOMER 980
- GLYCERIN
- ISOPROPYL MYRISTATE
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- TROLAMINE
- CITRAL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77807-003 | 77807-003-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| CARBOMER 980 | 4Q93RCW27E | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| CITRAL | T7EU0O9VPP | 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 |
|---|---|---|---|---|---|---|
| 4849298a-32c9-4794-91b3-22b38856cca1 | a48d1905-94b6-45b1-a0e0-ca96e5a84adc | 2022-01-24 | Warnings | 4849298a-32c9-4794-91b3-22b38856cca1 a48d1905-94b6-45b1-a0e0-ca96e5a84adc |