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.
Archele HS Gel EA 80%
- Manufacturer
- GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED
- Effective date
- 2021-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:36:45
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Label contents#
Full prescribing information#
Information
This is a hand sanitizer manufactured according to the
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active ingredients & Purpose
Antiseptic, Hand Sanitizer
OTC - PURPOSE SECTION
| Active ingreddient | Purpose |
| Alcohol 80% v/v ......... | Antiseptic |
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
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.
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, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
80 mL NDC: 74895-101-01
480 mL NDC: 74895-101-02
290 mL NDC: 74895-101-03
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74895-101-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa96-d8a0-e053-dadaa90a6e4e | Archele HS Gel EA 80% |
| 74895-101-02 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa96-d8a0-e053-dadaa90a6e4e | Archele HS Gel EA 80% |
| 74895-101-03 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa96-d8a0-e053-dadaa90a6e4e | Archele HS Gel EA 80% |
| 74895-101-04 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa96-d8a0-e053-dadaa90a6e4e | Archele HS Gel EA 80% |
| 74895-101-05 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa96-d8a0-e053-dadaa90a6e4e | Archele HS Gel EA 80% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74895-101-01 | Hand Sanitizer | 80 mL in 1 TUBE | GEL | 80 | 6 | |
| 74895-101-02 | Hand Sanitizer | 480 mL in 1 BOTTLE, PUMP | GEL | 480 | 6 | |
| 74895-101-03 | Hand Sanitizer | 290 mL in 1 BOTTLE, PUMP | GEL | 290 | 6 | |
| 74895-101-04 | Hand Sanitizer | 236 mL in 1 BOTTLE, PUMP | GEL | 236 | 6 | |
| 74895-101-05 | Hand Sanitizer | 60 mL in 1 BOTTLE, PUMP | GEL | 60 | 6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74895-101 | 74895-101-01, 74895-101-03, 74895-101-02, 74895-101-04, 74895-101-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | 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 |
|---|---|---|---|---|---|---|
| b8a3dfe6-643a-a98c-e053-2a95a90a21ed | a2baa7aa-5878-6173-e053-2995a90a2e74 | 2021-01-11 | Warnings | b8a3dfe6-643a-a98c-e053-2a95a90a21ed a2baa7aa-5878-6173-e053-2995a90a2e74 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.