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.
Serene Clean and Pure Hand Sanitizer Gel
- Manufacturer
- Serene Clean & Pure LLC
- Effective date
- 2020-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:21:39
Label at a glance#
ProductSerene Clean and Pure Hand Sanitizer Gel
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Contacts and useful links#
Websitewww.serenepure.com
www.serenepure.com
www.serenepure.comLabel contents#
Full prescribing information#
Active ingredient
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
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
Water, carbomer, glycerin
Package Label - Principal Display Panel
Serene Clean & Pure
Kills 99.9% of All Germs & Bacteria
Gel Hand Sanitizer
70% Isopropyl Alcohol
ABOUT
Serene Clean & Pure is a family owned company that believes in honest and helpful products.
Serene Clean & Pure is a quickly drying hand sanitizer that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life
Distributed by:
Serene Clean & Pure
555 Anton Blvd. Suite 105
Costa Mesa, CA 92626
2 fl. oz.
4 fl. oz.
8 fl. oz.
10 fl. oz.
16 fl. oz.
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78643-110-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
| 78643-110-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
| 78643-110-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
| 78643-110-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
| 78643-110-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
| 78643-110-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ac66-a426-e053-dadaa90af4c2 | Serene Clean & Pure Gel Hand Sanitizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78643-110-01 | Serene Clean and Pure Hand Sanitizer Gel | 3785.41 mL in 1 BOTTLE, PLASTIC | GEL | 3785.41 | 2 | |
| 78643-110-02 | Serene Clean and Pure Hand Sanitizer Gel | 59 mL in 1 BOTTLE, PLASTIC | GEL | 59 | 2 | |
| 78643-110-04 | Serene Clean and Pure Hand Sanitizer Gel | 118 mL in 1 BOTTLE, PLASTIC | GEL | 118 | 2 | |
| 78643-110-08 | Serene Clean and Pure Hand Sanitizer Gel | 236 mL in 1 BOTTLE, PLASTIC | GEL | 236 | 2 | |
| 78643-110-10 | Serene Clean and Pure Hand Sanitizer Gel | 296 mL in 1 BOTTLE, PLASTIC | GEL | 296 | 2 | |
| 78643-110-16 | Serene Clean and Pure Hand Sanitizer Gel | 296 mL in 1 BOTTLE, PLASTIC | GEL | 296 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Serene Clean and Pure Hand Sanitizer Gel
- Isopropyl Alcohol
- GLYCERIN
- WATER
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78643-110 | 78643-110-02, 78643-110-04, 78643-110-08, 78643-110-10, 78643-110-16, 78643-110-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | 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 |
|---|---|---|---|---|---|---|
| aa98e90a-483d-5095-e053-2a95a90af772 | a7c26a66-05ad-0fae-e053-2a95a90ad3cf | 2020-07-16 | Warnings | aa98e90a-483d-5095-e053-2a95a90af772 a7c26a66-05ad-0fae-e053-2a95a90ad3cf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.