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.
Hand Sanitizer Alcohol Antiseptic 70% Topical Gel
- Manufacturer
- Solugen, Inc. | Solugen, Inc
- Effective date
- 2020-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:26:34
Label at a glance#
ProductHand Sanitizer Alcohol Antiseptic 70% Topical Gel
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the part333A of the OTC monograph.
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)
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (1.5% v/v).
c. Hydroxymethyl Cellulose (1.3% v/v) .
d. Sterile distilled water or boiled cold water.
Active Ingredient(s)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
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 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 be signs 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
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, methylcellulose, purified water USP
Hand Sanitizer Alcohol Antiseptic 70% Topical Gel
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71158-003-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
| 71158-003-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
| 71158-003-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
| 71158-003-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
| 71158-003-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
| 71158-003-09 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6050-a426-e053-dadaa90af4c2 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71158-003-01 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 18927000 mL in 1 TANK | GEL | 18927000 | 2 | |
| 71158-003-02 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | GEL | 1249000 | 2 | |
| 71158-003-03 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 208198 mL in 1 DRUM | GEL | 208198 | 2 | |
| 71158-003-04 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 18927 mL in 1 DRUM | GEL | 18927 | 2 | |
| 71158-003-05 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 3785 mL in 1 PAIL | GEL | 3785 | 2 | |
| 71158-003-09 | Hand Sanitizer Alcohol Antiseptic 70% Topical Gel | 1000 mL in 1 BOTTLE | GEL | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer Alcohol Antiseptic 70% Topical Gel
- ALCOHOL
- GLYCERIN
- WATER
- HYDROXYMETHYL CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71158-003 | 71158-003-01, 71158-003-02, 71158-003-03, 71158-003-04, 71158-003-05, 71158-003-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| HYDROXYMETHYL CELLULOSE | 273FM27VK1 | 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 |
|---|---|---|---|---|---|---|
| ae434f02-9b66-32a1-e053-2995a90a8e07 | ae3f04b7-c7b1-dc15-e053-2a95a90ac8ef | 2020-09-01 | Warnings | ae434f02-9b66-32a1-e053-2995a90a8e07 ae3f04b7-c7b1-dc15-e053-2a95a90ac8ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.