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.
HAND SANITIZER
- Manufacturer
- SUN WAVE WELLNESS, LLC
- Effective date
- 2020-08-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:25:53
Label at a glance#
ProductHAND SANITIZER
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections
Label contents#
Full prescribing information#
Active Ingredient(s)
Alcohol 70% v/v
Purpose
Antiseptic
Use(s)
To help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Do not use
- on children less than 2 months of age
- on open skin wounds
- around eyes
- in ears and mouth
When using this product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
- avoid contact with broken skin
- do not inhale or ingest
Stop use and ask a doctor if
irritation or rash occurs.
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 or excessive heat above 40C (104F).
Inactive ingredients
Aloe Barbadensis (leaf) Extract, Fragrance, Glycerin, Purified Water
Manufactured by:
Sun Wave Wellness, LLC
1419 Chaffee Drive #101
Titusville, FL 32780-7933
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75023-003-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-af33-a426-e053-dadaa90af4c2 | VERSION 2: CORRECTION INTENDED TO REPLACE SETID SUBMISSION ENDING "..AB88E" CORRECTION: (1) BACK LABEL REPLACEMENT CONSUMER HAND SANITIZER; NON-EMERGENCY; ISOPROPYL ALCOHOL = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANITIZERS (CONSUMER) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75023-003-04 | HAND SANITIZER | 1.893 L in 1 BOTTLE | LIQUID | 1.893 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- HAND SANITIZER
- ISOPROPYL ALCOHOL
- WATER
- ALOE VERA LEAF
- GLYCERIN
- LIMONENE, (+)-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75023-003 | 75023-003-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LIMONENE, (+)- | GFD7C86Q1W | 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 |
|---|---|---|---|---|---|---|
| adca566b-e058-9c76-e053-2995a90aaf94 | a9b89b7a-e789-8afc-e053-2a95a90ab88e | 2020-08-26 | Warnings | adca566b-e058-9c76-e053-2995a90aaf94 a9b89b7a-e789-8afc-e053-2a95a90ab88e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.