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.
Atala Bio Hand Sanitizer
- Manufacturer
- Kemix Quimica, S.A. de C.V.
- Effective date
- 2020-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:29:40
Label at a glance#
ProductAtala Bio Hand Sanitizer
Active ingredientDIDECYLDIMONIUM CHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
Active Ingredient(s)
DIDECYLDIMONIUM CHLORIDE 0.25 % v/v. Purpose: Antiseptic
BENZALKONIUM CHLORIDE 0.1 % 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. Avoid Eye Contact.Flammable. Keep away from heat or flame. Do not ingest
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, purified water USP, MAGNESIUM DISODIUM EDTA, ISOPROPYL ALCOHOL,METHYL ALCOHOL
Package Label - Principal Display Panel
4 L NDC: 77396-050-01
250 mL (0.25 L) NDC: 77396-050-03
75 mL (0.075 L) NDC: 77396-050-02
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77396-050-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-953a-a426-e053-dadaa90af4c2 | af872984-e169-f533-e053-2a95a90acd5b |
| 77396-050-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-953a-a426-e053-dadaa90af4c2 | af872984-e169-f533-e053-2a95a90acd5b |
| 77396-050-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-953a-a426-e053-dadaa90af4c2 | af872984-e169-f533-e053-2a95a90acd5b |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77396-050-01 | Atala Bio Hand Sanitizer | 4 L in 1 BOTTLE, DISPENSING | GEL | 4 | 1 | |
| 77396-050-02 | Atala Bio Hand Sanitizer | 0.075 L in 1 BOTTLE, DISPENSING | GEL | 0.075 | 1 | |
| 77396-050-03 | Atala Bio Hand Sanitizer | 0.25 L in 1 BOTTLE, DISPENSING | GEL | 0.25 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Atala Bio Hand Sanitizer
- Didecyldimonium Chloride and Benzalkonium Chloride Liquid
- ISOPROPYL ALCOHOL
- MAGNESIUM DISODIUM EDTA
- WATER
- DIDECYLDIMONIUM CHLORIDE
- DIDECYLDIMONIUM
- GLYCERIN
- METHYL ALCOHOL
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77396-050 | 77396-050-01, 77396-050-02, 77396-050-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| MAGNESIUM DISODIUM EDTA | NDT563S5VZ | IACT |
| WATER | 059QF0KO0R | IACT |
| DIDECYLDIMONIUM CHLORIDE | JXN40O9Y9B | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYL ALCOHOL | Y4S76JWI15 | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | 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 |
|---|---|---|---|---|---|---|
| af872984-e15b-f533-e053-2a95a90acd5b | af872984-e169-f533-e053-2a95a90acd5b | 2020-09-17 | Warnings | af872984-e15b-f533-e053-2a95a90acd5b af872984-e169-f533-e053-2a95a90acd5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.