OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Ethyl Alcohol 62.0%
Instant Hand Sanitizer
- Manufacturer
- Rejoice International Corp. | China Ningbo Shangge Cosmetic Technology Corp.
- Effective date
- 2025-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:37
Label at a glance#
ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Antimicrobial
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- wet hands thoroughly with product
- briskly rub hands together until dry
- supervise children under 6 years in the use of this product
INDICATIONS & USAGE SECTION
Use:
- for handwashing to decrease bacteria on the skin
- recommended for repeated use
WARNINGS SECTION
Warnings:
For external use only.
Flammable. Keep away from heat and flame.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E), d&c red no. 33
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57337-084-01 | 2025-02-06 | C162847 | 48780-1 | 2cef2736-8961-d83d-e063-dadaa90ab31f | 4e05cceb-b8f3-48f7-e054-00144ff88e88 |
| 57337-084-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8961-d83d-e063-dadaa90ab31f | 4e05cceb-b8f3-48f7-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-084-01 | Instant Hand Sanitizer | 53 mL in 1 BOTTLE | GEL | 53 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Instant Hand Sanitizer
- Ethyl Alcohol
- D&C RED NO. 33
- ALCOHOL
- GLYCERIN
- PROPYLENE GLYCOL
- .ALPHA.-TOCOPHEROL ACETATE
- WATER
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57337-084 | 57337-084-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
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 |
|---|---|---|---|---|---|---|
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International Corp. | 4e05cceb-b8f3-48f7-e054-00144ff88e88 | 2025-02-06 | Warnings | 57337-084-01 57337-084 57337008401 2d761e9e-68c0-ffae-e063-6294a90ac509 4e05cceb-b8f3-48f7-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.