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.
Antiseptic Hand Sanitizer
- Manufacturer
- MiracleCorp Products
- Effective date
- 2020-04-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:08:25
Label at a glance#
ProductAntiseptic Hand Sanitizer
Active ingredientAlcohol
Label structure9 sections
Storage and handling
Store between 15-30C (59-86F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient[s]
Alcohol 80% v/v
Purpose
Antiseptic
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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 wound
OTC - WHEN USING SECTION
When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse throughly with water.
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
- Store between 15-30C (59-86F)
Inactive Ingredients
Hydrogen Peroxide, Glycerol, Distilled Water
PRINCIPAL DISPLAY PANEL - 103.5 ml Bottle Label
Alcohol Antiseptic 80%
Topical Solution
Antiseptic
Hand Sanitizer
Non-Sterile Solution
Made in Dayton, Ohio by Your Friends at
Buckeye™
VODKA
buckeyevodka.com
MiracleCorp
Premium Pet Products
miraclecorp.com
3.5 fl oz | 103.5 ml
DO NOT STORE ABOVE 86F
SAMPLE - NOT FOR SALE
NOT FOR CONSUMPTION
238910_041320
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61429-005-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3c0d-a426-e053-dadaa90af4c2 | Antiseptic Hand Sanitizer |
| 61429-005-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3c0d-a426-e053-dadaa90af4c2 | Antiseptic Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61429-005-20 | Antiseptic Hand Sanitizer | 103.5 mL in 1 BOTTLE, PLASTIC | SPRAY | 103.5 | 1 | |
| 61429-005-30 | Antiseptic Hand Sanitizer | 473.18 mL in 1 BOTTLE, PLASTIC | SPRAY | 473.18 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Antiseptic Hand Sanitizer
- Alcohol
- Hydrogen Peroxide
- Glycerin
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61429-005 | 61429-005-20, 61429-005-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Alcohol | 3K9958V90M | ACTIB |
| Hydrogen Peroxide | BBX060AN9V | IACT |
| Glycerin | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| 1cc9b8e0-7722-493a-b48e-a9bab0aa2642 | fd83de9f-15e5-464e-ae58-9a5d79d1ac0e | 2020-04-27 | Warnings | 1cc9b8e0-7722-493a-b48e-a9bab0aa2642 fd83de9f-15e5-464e-ae58-9a5d79d1ac0e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.