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.
Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel
- Manufacturer
- BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA
- Effective date
- 2020-12-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:34:43
Label at a glance#
ProductClean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel
Active ingredientALCOHOL
Label structure8 sections
Storage and handling
Store between 15-30 °C (59-86 °F) Avoid freezing and excessive heat above 40 °C (104 °F)
Label contents#
Full prescribing information#
Drug Facts Panel - Active Ingredients
Denatured Ethyl Alcohol 70% v/v. Purpose: Antiseptic.
Drug Facts Panel - Purpose
Purpose: Antiseptic.
Drug Facts Panel - Use
Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Drug Facts Panel - 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
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 - DO NOT USE SECTION
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.
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.
Drug Facts Panel - 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.
Drug Facts Panel - Other Information
Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat above 40 °C (104 °F)
Drug Facts Panel - Inactive Ingredients
Carbomer, Glycerin, Triethanolamine, Water.
Package Label - Principal Display Panel
200 ml, NDC 79916-001-01
500 ml, NDC 79916-001-02
1500 ml, NDC 79916-001-03
5000 ml, NDC 79916-001-04
3 ml, NDC 79916-001-05
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 79916-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-65fc-a426-e053-dadaa90af4c2 | NO CHANGES NOTIFICATION |
| 79916-001-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-65fc-a426-e053-dadaa90af4c2 | NO CHANGES NOTIFICATION |
| 79916-001-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-65fc-a426-e053-dadaa90af4c2 | NO CHANGES NOTIFICATION |
| 79916-001-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-65fc-a426-e053-dadaa90af4c2 | NO CHANGES NOTIFICATION |
| 79916-001-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-65fc-a426-e053-dadaa90af4c2 | NO CHANGES NOTIFICATION |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79916-001-01 | Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel | 200 mL in 1 BOTTLE | GEL | 200 | 2 | |
| 79916-001-02 | Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel | 500 mL in 1 BOTTLE | GEL | 500 | 2 | |
| 79916-001-03 | Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel | 1500 mL in 1 BOTTLE | GEL | 1500 | 2 | |
| 79916-001-04 | Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel | 5000 mL in 1 JUG | GEL | 5000 | 2 | |
| 79916-001-05 | Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel | 3 mL in 1 POUCH | GEL | 3 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79916-001 | CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL (ETHYL ALCOHOL) GEL [BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA] | 2 | Legacy NDC, 5 package rows | 20201208_ac0e6e22-e798-3789-e053-2995a90a0411.zip |
Products#
Every source-derived product name is available through these pages.
- Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel
- Ethyl Alcohol
- TROLAMINE
- ALCOHOL
- WATER
- GLYCERIN
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79916-001 | 79916-001-01, 79916-001-02, 79916-001-03, 79916-001-04, 79916-001-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TROLAMINE | 9O3K93S3TK | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | HHT01ZNK31 | 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 |
|---|---|---|---|---|---|---|
| b5e13221-4228-5f08-e053-2995a90a1f9f | ac0e6e22-e798-3789-e053-2995a90a0411 | 2020-12-07 | Warnings | b5e13221-4228-5f08-e053-2995a90a1f9f ac0e6e22-e798-3789-e053-2995a90a0411 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.