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.
DewMed Alcohol Free Antiseptic Topical Solution Hand Sanitizer
- Manufacturer
- DewMed LLC
- Effective date
- 2020-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:29:47
Label at a glance#
ProductDewMed Alcohol Free Antiseptic Topical Solution Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient[s]
Benzalkonium Chloride 0.1%
Purpose
Antiseptic
Use[s]
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. 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
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 (59-86F).
- Avoid freezing and excessive heat above 40°C (104F).
Inactive ingredients
Melaleuca Alternifolia (Tea Tree) Essential Oil, Polysorbate 20, Glycerin, Purified Water.
Questions or comments
1-877-847-0060 / info@dewmed.group
Package Labeling:
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80065-002-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7b87-a426-e053-dadaa90af4c2 | DewMed Alcohol Free Antiseptic Topical Solution Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80065-002-01 | DewMed Alcohol Free Antiseptic Topical Solution Hand Sanitizer | 100 mL in 1 BOTTLE | GEL | 100 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DewMed Alcohol Free Antiseptic Topical Solution Hand Sanitizer
- BENZALKONIUM CHLORIDE
- TEA TREE OIL
- POLYSORBATE 20
- GLYCERIN
- WATER
- BENZALKONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80065-002 | 80065-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TEA TREE OIL | VIF565UC2G | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| af86d2d3-bfec-d468-e053-2a95a90af0ad | af86d6b3-98cc-528b-e053-2995a90a7da9 | 2020-09-17 | Warnings | af86d2d3-bfec-d468-e053-2a95a90af0ad af86d6b3-98cc-528b-e053-2995a90a7da9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.