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.
Bernal Premium Hand Sanitizer
- Manufacturer
- Inflatables LLC | LABORATORIOS BREMER, S.A.
- Effective date
- 2020-05-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:13:47
Label at a glance#
ProductBernal Premium Hand Sanitizer
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
Drug Facts
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
Carbomer, Triethanolamine, Water
Package Label - Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74541-370-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-17 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-34 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
| 74541-370-37 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3d4c-a426-e053-dadaa90af4c2 | Bernal Hand Sanitizer - PLD 70% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74541-370-01 | Bernal Premium Hand Sanitizer | 30 mL in 1 BOTTLE, DISPENSING | GEL | 30 | 1 | |
| 74541-370-02 | Bernal Premium Hand Sanitizer | 60 mL in 1 BOTTLE, DISPENSING | GEL | 60 | 1 | |
| 74541-370-04 | Bernal Premium Hand Sanitizer | 130 mL in 1 BOTTLE, DISPENSING | GEL | 130 | 1 | |
| 74541-370-08 | Bernal Premium Hand Sanitizer | 220 mL in 1 BOTTLE, DISPENSING | GEL | 220 | 1 | |
| 74541-370-10 | Bernal Premium Hand Sanitizer | 300 mL in 1 BOTTLE, DISPENSING | GEL | 300 | 1 | |
| 74541-370-17 | Bernal Premium Hand Sanitizer | 500 mL in 1 BOTTLE, DISPENSING | GEL | 500 | 1 | |
| 74541-370-34 | Bernal Premium Hand Sanitizer | 1000 mL in 1 BOTTLE, DISPENSING | GEL | 1000 | 1 | |
| 74541-370-37 | Bernal Premium Hand Sanitizer | 3785 mL in 1 BOTTLE | GEL | 3785 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Bernal Premium Hand Sanitizer
- ALCOHOL
- CARBOMER 940
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74541-370 | 74541-370-01, 74541-370-02, 74541-370-04, 74541-370-08, 74541-370-10, 74541-370-17, 74541-370-34, 74541-370-37 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER 940 | 4Q93RCW27E | IACT |
| TROLAMINE | 9O3K93S3TK | 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 |
|---|---|---|---|---|---|---|
| 5734a239-85f7-3dad-e063-6394a90ac9e3 | a6051aeb-ab2a-3302-e053-2995a90aaf5e | 2026-07-22 | Warnings | a6051aeb-ab2a-3302-e053-2995a90aaf5e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.