Storage and handling
Other information • Store between 15–30C (59–86F) • Avoid freezing and excessive heat above 40C (104F)
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
- Manufacturer
- Sarkli-Repechage, Ltd.
- Effective date
- 2020-04-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:06:16
Label at a glance#
ProductAlcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
Active ingredientALCOHOL
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient[s]
Alcohol 80% v/v
OTC - PURPOSE SECTION
Purpose
Antiseptic
INDICATIONS & USAGE SECTION
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
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.
WARNINGS SECTION
Warnings
For external use only. Flammable. Keep away from heat or flame.
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.
OTC - STOP USE SECTION
Stop 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.
DOSAGE & ADMINISTRATION SECTION
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.
INSTRUCTIONS FOR USE SECTION
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.
STORAGE AND HANDLING SECTION
Other information
• Store between 15–30C (59–86F)
• Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
Inactive ingredients glycerin, hydrogen peroxide, purfied water USP
OTC - QUESTIONS SECTION
Questions or comments?
Call Toll-Free 1-800-SKIN (1-800-248-7546) Monday-Friday 9am-5:30pm ET
Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
118 mL, NDC 64521-5678-4
59 mL, NDC 64521-5678-2
236 mL, NDC 64521-5678-8
473 mL, NDC 64521-5678-1
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64521-5678-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6ed4-a426-e053-dadaa90af4c2 | Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution |
| 64521-5678-2 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6ed4-a426-e053-dadaa90af4c2 | Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution |
| 64521-5678-4 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6ed4-a426-e053-dadaa90af4c2 | Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution |
| 64521-5678-8 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6ed4-a426-e053-dadaa90af4c2 | Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64521-5678-1 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | 4 | |
| 64521-5678-2 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution | 59 mL in 1 BOTTLE, SPRAY | SOLUTION | 59 | 4 | |
| 64521-5678-4 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution | 118 mL in 1 BOTTLE, SPRAY | SOLUTION | 118 | 4 | |
| 64521-5678-8 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution | 236 mL in 1 BOTTLE, SPRAY | SOLUTION | 236 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64521-5678 | ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION (ALCOHOL) SOLUTION [SARKLI-REPECHAGE, LTD.] | 4 | Legacy NDC, 4 package rows | 20200415_a19c0b93-ae48-7b62-e053-2a95a90a701c.zip |
Products#
Every source-derived product name is available through these pages.
- Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
- Alcohol
- GLYCERIN
- WATER
- HYDROGEN PEROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64521-5678 | 64521-5678-4, 64521-5678-2, 64521-5678-8, 64521-5678-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | 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 |
|---|---|---|---|---|---|---|
| a33fd467-2fbd-7eee-e053-2995a90ae098 | a19c0b93-ae48-7b62-e053-2a95a90a701c | 2020-04-14 | Warnings | a33fd467-2fbd-7eee-e053-2995a90ae098 a19c0b93-ae48-7b62-e053-2a95a90a701c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.