Dosage and administration
Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary. Supervise children under 6 years with the use of this product. Do not use on infants.
Hand Sanitizer
- Manufacturer
- Charles and Associates, LLC
- Effective date
- 2020-07-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:23:08
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections
Storage and handling
Store at room temperature May discolor certain fabrics Harmful to wood finishes and plastics
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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):
- Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (0.5% v/v).
- Carbomer (8.0% v/v).
- Trolamine (1.0% v/v).
- Sterile distilled water or boiled cold water.
Active Ingredient(s)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic
Use
Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat and flame.
OTC - WHEN USING SECTION
Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.
Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation and redness develop and presists 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 poison control center right away.
Directions
- Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
- Supervise children under 6 years with the use of this product. Do not use on infants.
Other information
- Store at room temperature
- May discolor certain fabrics
- Harmful to wood finishes and plastics
Inactive ingredients
Deminerialized water, Carbopol 960, Triethanolamine, Glycerin
Package Label - Principal Display Panel
16.9 fl oz (500 ml) NDC: 78336-070-16
8.45 fl oz (250 ml) NDC: 78336-070-08
4.06 fl oz (120 ml) NDC: 78336-070-04
2.03 fl oz (60 ml) NDC: 78336-070-02
1 fl oz (30 ml) NDC: 78336-070-01
1 liter (1000ml) 33.8 fl oz NDC: 78336-070-10
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78336-070-01 | Hand Sanitizer | 30 mL in 1 BOTTLE, PLASTIC | GEL | 30 | 6 | |
| 78336-070-02 | Hand Sanitizer | 60 mL in 1 BOTTLE, PLASTIC | GEL | 60 | 6 | |
| 78336-070-04 | Hand Sanitizer | 120 mL in 1 BOTTLE, PLASTIC | GEL | 120 | 6 | |
| 78336-070-08 | Hand Sanitizer | 250 mL in 1 BOTTLE, PLASTIC | GEL | 250 | 6 | |
| 78336-070-10 | Hand Sanitizer | 1000 mL in 1 BOTTLE, PLASTIC | GEL | 1000 | 6 | |
| 78336-070-16 | Hand Sanitizer | 500 mL in 1 BOTTLE, PLASTIC | GEL | 500 | 6 | |
| 78336-070-37 | Hand Sanitizer | 3785 mL in 1 JUG | GEL | 3785 | 6 | |
| 78336-170-01 | Hand Sanitizer | 30 mL in 1 BOTTLE, PLASTIC | GEL | 30 | 6 | |
| 78336-170-02 | Hand Sanitizer | 60 mL in 1 BOTTLE, PLASTIC | GEL | 60 | 6 | |
| 78336-170-04 | Hand Sanitizer | 120 mL in 1 BOTTLE, PLASTIC | GEL | 120 | 6 | |
| 78336-170-08 | Hand Sanitizer | 250 mL in 1 BOTTLE, PLASTIC | GEL | 250 | 6 | |
| 78336-170-16 | Hand Sanitizer | 500 mL in 1 BOTTLE, PLASTIC | GEL | 500 | 6 | |
| 78336-170-37 | Hand Sanitizer | 3785 mL in 1 JUG | GEL | 3785 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 78336-070 | HAND SANITIZER (ETHYL ALCOHOL) GEL [CHARLES AND ASSOCIATES, LLC] | 6 | Legacy NDC, 7 package rows | 20200730_a7e74b63-9d4c-7baa-e053-2a95a90a98b2.zip |
| 78336-170 | HAND SANITIZER (ETHYL ALCOHOL) GEL [CHARLES AND ASSOCIATES, LLC] | 6 | Legacy NDC, 6 package rows | 20200730_a7e74b63-9d4c-7baa-e053-2a95a90a98b2.zip |
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- Ethyl Alcohol
- GLYCERIN
- CARBOMER 940
- WATER
- ALCOHOL
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78336-170 | 78336-170-37, 78336-170-16, 78336-170-08, 78336-170-04, 78336-170-02, 78336-170-01 |
| 78336-070 | 78336-070-37, 78336-070-16, 78336-070-08, 78336-070-04, 78336-070-02, 78336-070-01, 78336-070-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| TROLAMINE | 9O3K93S3TK | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| TROLAMINE | 9O3K93S3TK | 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 |
|---|---|---|---|---|---|---|
| ab9e549c-ab54-9fab-e053-2a95a90aa597 | a7e74b63-9d4c-7baa-e053-2a95a90a98b2 | 2020-07-29 | Warnings | ab9e549c-ab54-9fab-e053-2a95a90aa597 a7e74b63-9d4c-7baa-e053-2a95a90a98b2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.