Active Ingredients And Purpose
Active Ingredients
Medicinal ingredient: Ethyl alcohol 70% v/v............... Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
KleenSwell Gel Hand Sanitizer
- Manufacturer
- Hygienic Labs, LLC.
- Effective date
- 2020-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 23:35:09
Key Label Information#
Uses
Use
Hand Sanitizer to help reduce viruses and bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
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
Directions And Dosage
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 Label Information
Other Information
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENT SECTION
Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone
Package Label - Principal Product Label
3800 mL NDC: 79692-003-01 19000 mL NDC: 79692-003-05 189000 mL NDC: 79692-003-50 250 mL NDC: 79692-003-08 500 mL NDC: 79692-003-16
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 79692-003-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8079-a426-e053-dadaa90af4c2 | acf0fc2b-e3bf-307f-e053-2a95a90a0e9c |
| 79692-003-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8079-a426-e053-dadaa90af4c2 | acf0fc2b-e3bf-307f-e053-2a95a90a0e9c |
| 79692-003-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8079-a426-e053-dadaa90af4c2 | acf0fc2b-e3bf-307f-e053-2a95a90a0e9c |
| 79692-003-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8079-a426-e053-dadaa90af4c2 | acf0fc2b-e3bf-307f-e053-2a95a90a0e9c |
| 79692-003-50 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8079-a426-e053-dadaa90af4c2 | acf0fc2b-e3bf-307f-e053-2a95a90a0e9c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79692-003-01 | KleenSwell Gel Hand Sanitizer | 3800 mL in 1 JUG | GEL | 3800 | 7 | |
| 79692-003-05 | KleenSwell Gel Hand Sanitizer | 19000 mL in 1 PAIL | GEL | 19000 | 7 | |
| 79692-003-08 | KleenSwell Gel Hand Sanitizer | 250 mL in 1 BOTTLE, PLASTIC | GEL | 250 | 7 | |
| 79692-003-16 | KleenSwell Gel Hand Sanitizer | 500 mL in 1 BOTTLE, PLASTIC | GEL | 500 | 7 | |
| 79692-003-50 | KleenSwell Gel Hand Sanitizer | 189000 mL in 1 DRUM | GEL | 189000 | 7 |
DailyMed Dashboard NDC Coverage#
Products#
- KleenSwell Gel Hand Sanitizer
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79692-003 | 79692-003-01, 79692-003-50, 79692-003-05, 79692-003-08, 79692-003-16 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| TROLAMINE | 9O3K93S3TK | IACT |
| WEST INDIAN LEMONGRASS OIL | 5BIA40E9ED | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) | T967IEU43C | IACT |
| PEG-10 DIMETHICONE (600 CST) | 8PR7V1SVM0 | IACT |
| MYRISTYL LACTATE | 1D822OC34X | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
KLEENSWELL GEL HAND SANITIZER - 70% alcohol gel Hygienic Labs, LLC. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- This is hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).
Active Ingredients
Medicinal ingredient: Ethyl alcohol 70% v/v............... Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce viruses and 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
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.
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 INGREDIENT SECTION
Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone
RECENT MAJOR CHANGES SECTION
Dosage and Administration Section was added
Package Label - Principal Product Label
3800 mL NDC: 79692-003-01 19000 mL NDC: 79692-003-05 189000 mL NDC: 79692-003-50 250 mL NDC: 79692-003-08 500 mL NDC: 79692-003-16