Dosage and administration
Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision
Advanced Hand Sanitizer
- Manufacturer
- Sanare Bioscience | Sonare Bioscience
- Effective date
- 2020-06-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:17:05
Label at a glance#
ProductAdvanced Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
- Store between 15-30C. Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
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 World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold 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)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
For hand washing to decrease bacteria on the skin - recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
- in children less than 2 months of age
- on open skin wounds
OTC - WHEN USING SECTION
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 occurs. These may be
signs of a serious condition. Keep out of reach of children. I
swallowed, get medical help immediately or contact a Poison
Control Center immediately
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
Wet hands thoroughly with product, and allow to
dry without wiping. For children under six, use only under
adult supervision
Other information
- Store between 15-30C. Avoid freezing and
excessive heat above 40C (104F). May discolor some fabrics.
Harmful to wood finishes and plastics
Inactive ingredients
glycerin, hydrogen peroxide, Lemon Grass Fragrance, purified water USP
Package Label - Principal Display Panel
or
4 oz (118 mL) NDC: 78515-001-04
or
8 oz (236 mL) NDC: 78515-001-08
or
128 oz (3785 mL) NDC: 78515-001-28
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78515-001-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7490-a426-e053-dadaa90af4c2 | a71000cc-f836-55f8-e053-2995a90a0c63 |
| 78515-001-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7490-a426-e053-dadaa90af4c2 | a71000cc-f836-55f8-e053-2995a90a0c63 |
| 78515-001-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7490-a426-e053-dadaa90af4c2 | a71000cc-f836-55f8-e053-2995a90a0c63 |
| 78515-001-28 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7490-a426-e053-dadaa90af4c2 | a71000cc-f836-55f8-e053-2995a90a0c63 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78515-001-02 | Advanced Hand Sanitizer | 59 mL in 1 BOTTLE, PLASTIC | LIQUID | 59 | 2 | |
| 78515-001-04 | Advanced Hand Sanitizer | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 2 | |
| 78515-001-08 | Advanced Hand Sanitizer | 236 mL in 1 BOTTLE, PLASTIC | LIQUID | 236 | 2 | |
| 78515-001-28 | Advanced Hand Sanitizer | 3785 mL in 1 BOTTLE, PLASTIC | LIQUID | 3785 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Advanced Hand Sanitizer
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
- FRAGRANCE LAVENDER & CHIA F-153480
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78515-001 | 78515-001-02, 78515-001-04, 78515-001-08, 78515-001-28 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| FRAGRANCE LAVENDER & CHIA F-153480 | SXS9CO2TZK | 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 |
|---|---|---|---|---|---|---|
| a7bc380f-85df-a46e-e053-2a95a90ae4f2 | a71000cc-f836-55f8-e053-2995a90a0c63 | 2020-06-10 | Warnings | a7bc380f-85df-a46e-e053-2a95a90ae4f2 a71000cc-f836-55f8-e053-2995a90a0c63 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.