Indications and uses
Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Use: 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.
Other information: ● Store between 15-30 °C (59-86 °F) ● Avoid freezing and excessive heat above 40 °C (104 °F)
Denatured Ethyl Alcohol 70%. Purpose: Antiseptic
Purpose: Antiseptic.
Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.
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.
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.
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 15-30 °C (59-86 °F)
● Avoid freezing and excessive heat above 40 °C (104 °F)
Inactive ingredients:
Aminomethyl Propanol, Carbomer, Glycerin, Water.
Questions or reporting of adverse events?
Contact weekdays from 9AM to 5PM at 1-786-272-5677
60 ml NDC 78904-001-01
200 ml NDC 78904-001-02
400 ml NDC 78904-001-03
500 ml NDC 78904-001-04
1000 ml NDC 78904-001-05
5000 ml NDC 78904-001-06
5 ml NDC 78904-001-07
Level 1
50x5 ml NDC 78904-001-07
Level 2
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78904-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| 78904-001-07 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e89b-a426-e053-dadaa90af4c2 | NO CHANGE NOTIFICATION |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78904-001-01 | Fashion Antiseptic Gel Hand Sanitizer | 60 mL in 1 BOTTLE | GEL | 60 | 2 | |
| 78904-001-02 | Fashion Antiseptic Gel Hand Sanitizer | 200 mL in 1 BOTTLE | GEL | 200 | 2 | |
| 78904-001-03 | Fashion Antiseptic Gel Hand Sanitizer | 400 mL in 1 BOTTLE | GEL | 400 | 2 | |
| 78904-001-04 | Fashion Antiseptic Gel Hand Sanitizer | 500 mL in 1 BOTTLE | GEL | 500 | 2 | |
| 78904-001-05 | Fashion Antiseptic Gel Hand Sanitizer | 1000 mL in 1 BOTTLE | GEL | 1000 | 2 | |
| 78904-001-06 | Fashion Antiseptic Gel Hand Sanitizer | 5000 mL in 1 JUG | GEL | 5000 | 2 | |
| 78904-001-07 | Fashion Antiseptic Gel Hand Sanitizer | 50 in 1 CARTON | GEL | 50 | 2 | |
| 78904-001-07 | Fashion Antiseptic Gel Hand Sanitizer | 5 mL in 1 POUCH | GEL | 5 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78904-001 | 78904-001-01, 78904-001-02, 78904-001-03, 78904-001-04, 78904-001-05, 78904-001-06, 78904-001-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| AMINOMETHYLPROPANOL | LU49E6626Q | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
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 |
|---|---|---|---|---|---|---|
| b78630a7-5b64-f3fc-e053-2995a90a647b | aa552a69-068a-44e4-e053-2a95a90a3631 | 2020-12-28 | Warnings | b78630a7-5b64-f3fc-e053-2995a90a647b aa552a69-068a-44e4-e053-2a95a90a3631 |
Adverse event summaries are temporarily unavailable. Other product information remains available.