Storage and handling
-Store between 15-30C (59-86F) -Avoid freezing and excessive heat above 40C (104F)
CleenScent Hand Sanitizer Gel
- Manufacturer
- XMA Servicios de Manufactura S de RL de CV
- Effective date
- 2020-08-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:19:07
Label at a glance#
ProductCleenScent Hand Sanitizer Gel
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020).
The hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product, with percentages iof the active ingredient consistent with the above mentioned final rule, Isopropyl Alcohol (70%, v/v).
OTC - ACTIVE INGREDIENT SECTION
Isopropyl Alcohol 70% v/v. Purpose: Antiseptic
OTC - PURPOSE SECTION
Hand Sanitizer
INDICATIONS & USAGE SECTION
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
WARNINGS SECTION
For external use only. Flammable. Keep away from heat or flame
OTC - DO NOT USE SECTION
-in children less than 2 months of age
-on open skin wounds
OTC - WHEN USING SECTION
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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
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.
STORAGE AND HANDLING SECTION
-Store between 15-30C (59-86F)
-Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
glycerin, purified water USP, carbomer, trolamine
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78108-1704-4 | 2024-12-10 | C162847 | 48780-1 | d6a99b39-f907-a426-e053-dadaa90af4c2 | CleenScent Hand Sanitizer Gel 330 ml |
| 78108-1704-4 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f907-a426-e053-dadaa90af4c2 | CleenScent Hand Sanitizer Gel 330 ml |
Products#
Every source-derived product name is available through these pages.
- CleenScent Hand Sanitizer Gel
- Isopropyl Alcohol
- WATER
- GLYCERIN
- CARBOMER 940
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78108-1704 | 78108-1704-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER 940 | 4Q93RCW27E | 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 |
|---|---|---|---|---|---|---|
| 28f05174-efb7-d739-e063-6294a90a5b13 | ac38da41-ff3b-50f0-e053-2a95a90add71 | 2024-12-10 | Warnings | ac38da41-ff3b-50f0-e053-2a95a90add71 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.