Dosage and administration
APPLY ENOUGH OF THIS PRODUCT TO COVER THE ENTIRE SURFACE OF YOUR HANDS INCLUDING THE FINGERTIPS, CUTICLES, AND WRISTS. THOROUGHY RUB HANDS TOGETHER UNTIL COMPLETELY DRY. NO NEED TO RINSE HANDS AFTER USING THIS PRODUCT..
Hand Sanitizer
- Manufacturer
- CLASSIC WINE VINEGAR COMPANY INC
- Effective date
- 2020-04-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:09:06
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections
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).
- Purified 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)
DENATURED ETHANOL AND GLYCERIN
Purpose
THIS PRODUCT IS AN ANTIMICROBIAL HAND SANITIZER THAT MEETS THE REQUIREMENTS OF THE USDA TO BE USED AS AN E3 ANTIMICROBIAL HAND SANITIZER.
SANITIZES HANDS TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
FLAMMABLE LIQUID AND VAPOR. KEEP AWAY FROM FLAME.
CAUSES SERIOUS EYE IRRITATION. IF IT GETS IN YOUR EYES RINSE WITH WATER FOR SEVERAL MINUTES. IF IRRITATION PERSISTS SEEK MEDICAL ATTENTION.
HARMFUL IF SWALLED SEEK MEDICAL ATTENTION OR CALL POISON CONTROL CENTER IMMEDIATELY.
IT IS MPORTANT TO KEEP AWAY FROM HEAT, SPARKS, OPEN FLAMES AND HOT SURFACES AS THIS PRODUCT IS HIGHLY FLAMMABLE. USE CAUTION AROUND AREAS WITH STATIC DISCHARGE. AKE SURE LID IS SEALED TIGHTLY AFTER USE.
OTC - WHEN USING SECTION
CAUSES SERIOUS EYE IRRITATION. IF IT GETS IN YOUR EYES RINSE WITH WATER FOR SEVERAL MINUTES. IF IRRITATION PERSISTS SEEK MEDICAL ATTENTION. HARMFUL IF SWALLOWED. SEEK MEDICAL ATTENTION OR CALL POISON CONTROL CENTER IMMEDIATELY
Directions
APPLY ENOUGH OF THIS PRODUCT TO COVER THE ENTIRE SURFACE OF YOUR HANDS INCLUDING THE FINGERTIPS, CUTICLES, AND WRISTS. THOROUGHY RUB HANDS TOGETHER UNTIL COMPLETELY DRY. NO NEED TO RINSE HANDS AFTER USING THIS PRODUCT..
Inactive ingredients
glycerin, purified water USP
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN
Package Label - Principal Display Panel
50mL NDC: 75600-807-50
3785mL NDC: 75600-807-01
208197mL NDC: 75600-807-55
1040988 mL NDC: 75600-807-27
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75600-807-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-25 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-27 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-50 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
| 75600-807-55 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8a47-a426-e053-dadaa90af4c2 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75600-807-01 | Hand Sanitizer | 3785 mL in 1 BOTTLE, PLASTIC | LIQUID | 3785 | 1 | |
| 75600-807-04 | Hand Sanitizer | 15141 mL in 1 BOTTLE, PLASTIC | LIQUID | 15141 | 1 | |
| 75600-807-12 | Hand Sanitizer | 125 mL in 1 BOTTLE, PLASTIC | LIQUID | 125 | 1 | |
| 75600-807-25 | Hand Sanitizer | 250 mL in 1 BOTTLE, PLASTIC | LIQUID | 250 | 1 | |
| 75600-807-27 | Hand Sanitizer | 1040988 mL in 1 BAG | LIQUID | 1040988 | 1 | |
| 75600-807-50 | Hand Sanitizer | 1 mL in 1 BOTTLE, PLASTIC | LIQUID | 1 | 1 | |
| 75600-807-55 | Hand Sanitizer | 208197 mL in 1 DRUM | LIQUID | 208197 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75600-807 | 75600-807-01, 75600-807-04, 75600-807-50, 75600-807-27, 75600-807-55, 75600-807-12, 75600-807-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a3baa00a-24f1-55cf-e053-2a95a90ac1a0 | a3ba9fa7-d41d-9918-e053-2995a90ac2f8 | 2020-04-20 | Warnings | a3baa00a-24f1-55cf-e053-2a95a90ac1a0 a3ba9fa7-d41d-9918-e053-2995a90ac2f8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.